Data / Medical devices / Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua (QKR): 246 FDA-registered makers in 20 countries

Name: FDA-registered makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

246 establishments in 20 countries are registered with the FDA to make Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua (product code QKR, Class N). 0 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this device Makers in China Watch this device

Product code: QKR
Device class: N
Medical specialty: Unknown

Makers by country

Country	Makers
China	174
Taiwan	15
South Korea	14
United States	9
Vietnam	7
Hong Kong	4
Mexico	4
India	3
Cambodia	3
Pakistan	2
Turkey	2
Bangladesh	1
Malaysia	1
Germany	1
Italy	1
Paraguay	1
Egypt	1
Kenya	1
United Kingdom	1
Thailand	1

Makers of Face Mask Within The Scope Of The Face Mask And Barrier Face Covering Enforcement Policy Or Face Mask Umbrella Eua

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

Maker	Location	Role	Source
A&a Product Manufacturing Limited	ShaTin,New Territories, Hong Kong	Exporter to the US, Manufacturer	api.fda.gov
Acme Filter Mask Inc.	New Taipei City, Taiwan	Exporter to the US, Manufacturer	api.fda.gov
Altor Safety	Valley Cottage, NY, United States	Manufacturer	api.fda.gov
Ammar Apparel Ii S. De R.L De C.V.	CALKINI Campeche, Mexico	Contract manufacturer	api.fda.gov
An Lanh Investment And Trading Company Limited	Thanh Nam Ward Ninh Binh, Vietnam	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Anhui Xuanwuyan Pharmaceutical Co.,ltd	Fuyang Anhui, China	Manufacturer	api.fda.gov
Anji Hongde Medical Products Co., Ltd.	HUZHOU Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Anji Spenq Industrial Co., Ltd.	Huzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Anqing Jiaxin Medical Technology Co., Ltd.	Anqing Anhui, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Arrow Medsource Group Limited	Hongkong, China	Exporter to the US, Specification developer	api.fda.gov
Authentic Brands Korea Co.,ltd	Mungyeong-si Gyeongbuk, South Korea	Manufacturer	api.fda.gov
Ayida (xiamen) P&C Technology Co., Ltd	Xiamen Fujian, China	Manufacturer	api.fda.gov
Anqing Mayfield Medical Limited	Anqing Anhui, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Bandex Industrial Corp.	Zhuhai City Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Baron (china) Co., Ltd	Quanzhou Fujian, China	Manufacturer	api.fda.gov
Baylab Usa	Dallas, TX, United States	Manufacturer, Repackager or relabeler	api.fda.gov
Beijing Biosis Healing Biological Technology Co., Ltd	Beijing, China	Manufacturer	api.fda.gov
Beijing ZKSK Technology Co., Ltd.	beijing, China	Contract manufacturer, Manufacturer	api.fda.gov
Beximco Ppe Limited	Dhaka Dhaka(Division), Bangladesh	Contract manufacturer	api.fda.gov
BNX Converting, LLC	Houston, TX, United States	Manufacturer	api.fda.gov
Bong Bach Tuyet Joint Stock Company	Ho Chi Minh, Vietnam	Manufacturer	api.fda.gov
Breathh Inc	San Diego, CA, United States	Contract manufacturer	api.fda.gov
Beijing Beishute Maternity & Child Articles Co., Ltd.	Beijing, China	Contract manufacturer, Foreign private label distributor	api.fda.gov
Betamars (HK) International, Ltd.	Hong Kong, Hong Kong	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Carenow Medical Pvt Ltd	Coimbatore Tamil Nadu, India	Complaint file establishment, Manufacturer	api.fda.gov
Changzhou 3R Medical Device Technology Co., Ltd.	Changzhou Jiangsu, China	Manufacturer	api.fda.gov
Changzhou Dailys Care Products Co.,ltd.	Changzhou Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Changzhou Hongtai Paper Film Co., Ltd	Changzhou Jiangsu, China	Contract manufacturer, Manufacturer	api.fda.gov
Changzhou Major Medical Products Co., Ltd.	CHANGZHOU Jiangsu, China	Manufacturer	api.fda.gov
Changzhou Meiguan Care Products Technology Co.,ltd.	Changzhou Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Changzhou Recoo Healthcare Co., Ltd.	Changzhou Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Chengde Technology Co., Ltd	Longgang Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Chengdu Sani Medical Equipment Co.,ltd.	Chengdu Sichuan, China	Exporter to the US, Manufacturer	api.fda.gov
China Surgical Dressings Center Co.,ltd	CHANGHWA CITY, FU-TIEN LI Changhua, Taiwan	Manufacturer, Repackager or relabeler	api.fda.gov
Chinamed Products (china) Ltd.	Gaoyao District Guangdong, China	Manufacturer	api.fda.gov
Conod Medical Co.,Limited	Changshu Jiangsu, China	Contract manufacturer	api.fda.gov
Crown Name Disposable Hygiene Products Fty. Ltd.	Wuhan Hubei, China	Manufacturer	api.fda.gov
Dalian Sundly Home Products Co.,ltd.	Dalian Liaoning, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Dongguan Sengtor Plastics Products Co., Ltd.	Dongguan Guangdong, China	Manufacturer	api.fda.gov
Dongguan Supercare Medical Products Co., Ltd	Dongguan Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Durio Ppe Sdn. Bhd.	Johor Bahru, Malaysia	Contract manufacturer, Manufacturer	api.fda.gov
Dongguan City Ruimi Gift Products Co Ltd	Dongguan Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Dongguan Mars Medical Products Co., Ltd.	Dongguan City Guangdong, China	Manufacturer	api.fda.gov
E-Way Viet Nam Company Limited	Long Khanh Dong Nai, Vietnam	Exporter to the US, Manufacturer	api.fda.gov
Ecollink Non-Woven Company Limited	Hongkong, China	Exporter to the US, Manufacturer	api.fda.gov
Everaid Co., Ltd.	YANGSAN-SI Gyeongnam, South Korea	Manufacturer	api.fda.gov
Fashion Zone Co., Ltd	Yiwu Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Foshan Nanhai Plus Medical Co Ltd	Foshan Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Foshan Niceday Sanitary Products Co., Ltd.	Foshan Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Foshan Special Medical Co., Ltd	FOSHAN CITY Guangdong, China	Manufacturer	api.fda.gov
Fujian BBC Inc	Quanzhou Fujian, China	Manufacturer	api.fda.gov
Fujian Quanzhoucity Aile Hygiene Products Co.,ltd.	Nanan City Fujian, China	Manufacturer	api.fda.gov
Fujian Tonggang Industries Ltd.	Quanzhou Fujian, China	Exporter to the US, Manufacturer	api.fda.gov
Fullstar Non-Woven Products Co.,ltd.	Xiantao City Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Fung Lead Medical & Sports Co., Ltd.	Nantou City, Taiwan	Exporter to the US, Manufacturer	api.fda.gov
Fujian Hui'an Hecheng Household Products Co., Ltd	Quanzhou Fujian, China	Manufacturer	api.fda.gov
Grupo Alyger, S.A. De C.V.	Guadalupe Nuevo Leon, Mexico	Contract manufacturer, Manufacturer	api.fda.gov
Guang Zhou He Chang Optical Co., Ltd.	Guangzhou Guangdong, China	Manufacturer	api.fda.gov
Guangdong Ecan Medical Co,ltd	Guangzhou Guangdong, China	Manufacturer	api.fda.gov
Guangdong Golden Leaves Technology Development Co., Ltd.	Dongguan Guangdong, China	Manufacturer	api.fda.gov
Guangdong Kangshen Medical Technology Co.,ltd.	ZHAOQING Guangdong, China	Manufacturer	api.fda.gov
Guangdong Maidi Medical Co.,ltd	Qingyuan Guangdong, China	Manufacturer	api.fda.gov
Guangdong Shunde New Sense Hygiene Products Co.,ltd	FOSHAN Guangdong, China	Manufacturer	api.fda.gov
Guangxi Shuya Health Care-Products Co., Ltd.	Nanning Guangxi, China	Manufacturer	api.fda.gov
Guangzhou Nanqixing Nonwoven Co., Ltd.	guangzhou Guangdong, China	Manufacturer	api.fda.gov
Guangzhou Nuoning Medical Supplies Co.,ltd	Guangzhou Guangdong, China	Manufacturer	api.fda.gov
Guangzhou Oo Medical Scientific Limited	Guangzhou Guangdong, China	Manufacturer	api.fda.gov
Guardmed Healthcare KH Co., Ltd.	Bati District Takeo, Cambodia	Manufacturer	api.fda.gov
Haimen Shengbang Laboratory Equipment Co., Ltd	Haimen Jiangsu, China	Manufacturer	api.fda.gov
Hanghai Medical Products Co Ltd	Jinhua City Zhejiang, China	Manufacturer	api.fda.gov
Hangzhou Coco Healthcare Products Co.,ltd.	Hangzhou Zhejiang, China	Manufacturer	api.fda.gov
Hangzhou Qianzhiya Sanitary Products Co.,ltd	Hangzhou Zhejiang, China	Manufacturer	api.fda.gov
Hangzhou Wise Medical Device Co.,ltd	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Hans Hepp GMBH & Co. KG	HAMBURG Lower Saxony, Germany	Manufacturer	api.fda.gov
Healgen Scientific LLC	Houston, TX, United States	Complaint file establishment, Specification developer	api.fda.gov
Health & Health (group) Co.,ltd	Guangzhou Guangdong, China	Manufacturer	api.fda.gov
Hebei Youjie Medical Devices Co., Ltd	Shijiazhuang Hebei, China	Exporter to the US, Manufacturer	api.fda.gov
Hefei Box Medical Innovation Co., Ltd	Hefei City Anhui, China	Contract manufacturer, Manufacturer	api.fda.gov
Hefei Jingcheng Plastic Products Co. Ltd	Hefei Anhui, China	Manufacturer	api.fda.gov
Henan Huibo Medical Co., Ltd	Nanyang City Henan, China	Manufacturer	api.fda.gov
Hengshui Gangsheng Medical Instruments Co., Ltd	Hengshui Hebei, China	Manufacturer	api.fda.gov
Hilbro International (pvt) Limited	SIALKOT Punjab, Pakistan	Contract manufacturer, Manufacturer	api.fda.gov
Hua Jing Medical Supplies Inc.	New Taipei City, Taiwan	Manufacturer	api.fda.gov
Huaian Angel Medical Instrument Co., Ltd	Huaian Jiangsu, China	Manufacturer	api.fda.gov
Hubei Deming Healthcare Products Co.,ltd.	Xiantao Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Hubei Deming Healthcare Products Co.,ltd.first Branch	Xiantao City Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Hubei Feiteng Protective Products Co.,ltd	Xiantao Hubei, China	Manufacturer	api.fda.gov
Hubei Huanfu Plastic Products Co., Ltd	HANCHUAN CITY Hubei, China	Manufacturer	api.fda.gov
Hubei Kimsoul Industrial Co.,ltd	Xiantao Hubei, China	Contract manufacturer, Manufacturer, Repackager or relabeler	api.fda.gov
Hubei Lioncare Protective Products Co., Ltd.	wuhan Hubei, China	Manufacturer	api.fda.gov
Hubei Qifu Protective Products Co.,ltd	Xiantao Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Hubei V-Medical Products Co., Ltd.	Xiantao Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Hubei Wanli Protective Products Co.,ltd	xiantao Hubei, China	Manufacturer	api.fda.gov
Hubei Weikang Protective Products Co.ltd	XIANTAO Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Hubei Xianbao Medical Health Products Co., Ltd.	Xiantao City, Hubei Province, China	Contract manufacturer, Manufacturer	api.fda.gov
Hubei Xianmeng Health Protection Commodity.,ltd	Xiantao Hubei, China	Manufacturer	api.fda.gov
Hubei Yazhi Hygiene Products Co., Ltd	Xiantao City Hubei, China	Manufacturer	api.fda.gov
Heaven Healthcare Co., Ltd.	Shaoxing Zhejiang, China	Manufacturer	api.fda.gov
Hubei Yi-Ya Protective Products Co., Ltd.	Xiantao Hubei, China	Manufacturer	api.fda.gov
Hynaut Health Technology Co., LTD.	Qingdao Shandong, China	Manufacturer	api.fda.gov
I-Ming Sanitary Materials Co., Ltd.	Changhua, Taiwan	Manufacturer	api.fda.gov
Indaco S.R.L.	Filiano Potenza, Italy	Manufacturer	api.fda.gov
Inno-Health Technology Co., Ltd.	Taichung City, Taiwan	Manufacturer	api.fda.gov
Insoftb(china) Co., Ltd.	JINJIANG Fujian, China	Exporter to the US, Manufacturer	api.fda.gov
Insumos Desechables Para La Salud S.A. De CV.	Tecoh Yucatan, Mexico	Manufacturer	api.fda.gov
Jiangsu Huadong Medical Device Industry Co., Ltd.	YANGZHOU CITY, Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Jiangsu Jumao X-Care Medical Equipment Co., Ltd	Danyang Jiangsu, China	Manufacturer	api.fda.gov
Jiangsu Yulong Medical Technology Co., Ltd.	Yangzhou Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer	api.fda.gov
Jiangxi Aicare Medical Technology Co., Ltd	Fuzhou Jiangxi, China	Exporter to the US, Manufacturer	api.fda.gov
Jiangyin City Ruirun Clothing Co., Ltd.	Jiangyin City Jiangsu, China	Manufacturer	api.fda.gov
Jiangyin Everise Medical Equipment Co., Ltd.	Jiangyin Jiangsu, China	Manufacturer	api.fda.gov
Jiangyin Mengjia Nonwoven Fabric Co.,ltd	Jiangyin Jiangsu, China	Manufacturer	api.fda.gov
Jiangyin Unixcare Medical Devices Co.,ltd	Jiangyin Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Jiarui Invest Industry Co., Ltd.	Hsien Changhua, Taiwan	Manufacturer	api.fda.gov
Jiaxing Xinyi Medical Instrument Co., Ltd.	Jiashan City Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Jingmen Huasheng Asia Dynamics Sanitary Products Co., Ltd.	Jingmen City Hubei, China	Contract manufacturer, Manufacturer, Repackager or relabeler	api.fda.gov
Jinhua Jingdi Medical Supplies Co.,ltd	Jinhua Zhejiang, China	Manufacturer	api.fda.gov
Jan Mao Industries Co., Ltd.	Guangxi Zhuang Autonomous Region, China	Exporter to the US, Manufacturer	api.fda.gov
Jiangsu Guangda Medical Material Group Co., Ltd.	Haian Jiangsu, China	Manufacturer	api.fda.gov
Jiangsu Newvalue Medical Products Co., Ltd.	Taizhou Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Jiangyin Huashi Medical Equipment Co.,Ltd	Jiangyin City Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Kao Chen Enterprise Co., Ltd.	Taichung City, Taiwan	Manufacturer	api.fda.gov
Kim Sora Corporation	Hoa Khanh Ward Da Nang, Vietnam	Manufacturer	api.fda.gov
Korea Ogk Co., Ltd.	Chilgok-gun Gyeongbuk, South Korea	Manufacturer	api.fda.gov
Kunshan Yari Sanitary Products Co., Ltd.	Kunshan Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Kyungin Flax Co.,ltd	Ansan-si Gyeonggi, South Korea	Manufacturer	api.fda.gov
Lambi, S.A. De C.V.	Escobedo Nuevo Leon, Mexico	Foreign private label distributor, Manufacturer	api.fda.gov
Laserpair Co.,limited	Shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Liaoning Bosen Medical Devices & Technologies Co., Ltd	BenXi Liaoning, China	Contract manufacturer, Exporter to the US, Manufacturer, Remanufacturer	api.fda.gov
Linyi Standard Textile Co Ltd	Linyi Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
LLRN Personal Care (shenzhen) Co.,ltd	shenzhen Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Lty Co., Ltd.	Hwaseong-si Gyeonggi, South Korea	Manufacturer	api.fda.gov
LTY Jeonju Factory Co., Ltd.	Wanju-gun Jeonbuk, South Korea	Manufacturer	api.fda.gov
Magnum Health And Safety Pvt Ltd	TALUKA - VASAI PALGHAR Maharashtra, India	Manufacturer	api.fda.gov
MB Regentox Vietnam Trading Service Company Limited	Ho Chi Minh City, Vietnam	Foreign private label distributor, Manufacturer	api.fda.gov
Mctbio	Yongin-si Gyeonggi, South Korea	Manufacturer	api.fda.gov
MDK (shanghai) Medical Packing Co., Ltd	Shanghai, China	Contract manufacturer, Manufacturer	api.fda.gov
Mediana Co., Ltd.	Wonju-Si, Gangwon-do, South Korea	Manufacturer	api.fda.gov
MEDLINE INDUSTRIES, LP - Northfield	Northfield, IL, United States	Specification developer	api.fda.gov
Mega Plasticos SA	Minga Guazu Alto Parana, Paraguay	Exporter to the US, Manufacturer	api.fda.gov
Megasoft (china) Co.,ltd.	Shishi Fujian, China	Manufacturer	api.fda.gov
Ming Fai Enterprise (cambodia) Co.,ltd	Samraong Tong District Kampong Speu, Cambodia	Manufacturer	api.fda.gov
Ming Fai Industrial (shenzhen) Co. Ltd.	SHENZHEN Guangdong, China	Contract manufacturer	api.fda.gov
Miracle Medical Industries	El Obour City Al Qahirah, Egypt	Manufacturer	api.fda.gov
Modern Healthcare Corp.	TIEN CHUNG COUNTY, CHANG-HWA Changhua, Taiwan	Exporter to the US, Manufacturer	api.fda.gov
Medifirst Co.,Ltd.	Cheonan-si, Chungnam, South Korea	Manufacturer	api.fda.gov
Nan'an Hengyuan Hygiene Products Co., Ltd.	Nanan Fujian, China	Exporter to the US, Manufacturer	api.fda.gov
Neomed Co., Ltd.	Saha-gu Busan, South Korea	Manufacturer	api.fda.gov
Neomedi Pharm Inc.	GOYANG-SI Gyeonggi, South Korea	Manufacturer	api.fda.gov
Ningbo Chibanda Imp &exp Co, Ltd	Ningbo Zhejiang, China	Manufacturer	api.fda.gov
Ningbo Greetmed Medical Instruments Co., Ltd.	Ningbo Zhejiang, China	Exporter to the US, Specification developer	api.fda.gov
Ningbo Just Soon Industrial Limited	Ningbo Zhejiang, China	Exporter to the US, Manufacturer, Repackager or relabeler	api.fda.gov
Ningbo Luke Medical Devices Co., Ltd.	Yuyao Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.	Ningbo Zhejiang, China	Manufacturer	api.fda.gov
Ningjin Runboda Medical Protective Products Co., Ltd.	Xingtai Hebei, China	Exporter to the US, Manufacturer	api.fda.gov
NMS Technologies	NANJING Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
North Coast Medical, Inc.	Morgan Hill, CA, United States	Manufacturer	api.fda.gov
Nuga Medical Co Ltd	Wonju Gangwon, South Korea	Manufacturer	api.fda.gov
Ningbo Troika Science & Technology Co.,Ltd.	Ningbo Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Pergo Medikal Ve Ilac Sanayi Anonim Sirketi	Izmir, Turkey	Manufacturer	api.fda.gov
Podo Xingda (tianjin) Medical Co., Ltd.	Tianjin, China	Manufacturer	api.fda.gov
Polison Corporation Pingtung Export Processing Zone Factory	Pingtung City, Taiwan	Manufacturer	api.fda.gov
Power Well Healthcare Technology Co., Ltd.	Changhua County, Taiwan	Exporter to the US, Manufacturer	api.fda.gov
Professional Products, Inc.	Defuniak Spgs, FL, United States	Manufacturer	api.fda.gov
Principle & Will Biotech (Pinghu) Co., Ltd.	Pinghu City Zhejiang, China	Manufacturer	api.fda.gov
Qinhuangdao Taizhi Medical Technology Co., Ltd	Qinhuangdao Hebei, China	Manufacturer	api.fda.gov
Quang Nam Medical Devices Factory Branch Of Danameco Medical Joint Stock Corporation	Dien Ban Bac Ward Da Nang, Vietnam	Contract manufacturer, Manufacturer	api.fda.gov
Quanzhou Huifeng Sanitary Articles Co.,ltd	QUANZHOU Fujian, China	Manufacturer	api.fda.gov
Qingdao Likangyuan Medical Device Co.,Ltd.	Qingdao Shandong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Quanzhou Tianjiao Lady & Baby's Hygiene Supply Co., Ltd.	Quanzhou Fujian, China	Manufacturer	api.fda.gov
RFI Hygiene Limited	Shanghai, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Rfx+care Manufacturing Co., Ltd.	Shaoxing Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Riccino (xiamen) Optical Inc.	Xiamen Fujian, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Safeway Industry Healthcare	Xiantao Hubei, China	Manufacturer	api.fda.gov
Samaritan Textile (cambodia) Co., Ltd.	Phnom Penh, Cambodia	Manufacturer	api.fda.gov
Savewo Limited	New Territories, Hong Kong	Contract manufacturer, Manufacturer	api.fda.gov
Shandong Haidike Medical Products Co., Ltd	Heze Shandong, China	Manufacturer	api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., Ltd	Heze Shandong, China	Manufacturer	api.fda.gov
Shanghai Link Instruments Co.,ltd	Changzhou City Jiangsu, China	Manufacturer	api.fda.gov
Shenzhen Mondial Technology Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Shenzhen Spectrum Eyewear Limited	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Shenzhen Tengda Zhichuang Technology Co., Ltd.	shenzhen Guangdong, China	Exporter to the US, Manufacturer	api.fda.gov
Shenzhen Youmay Electronics Co., Ltd	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Silverfox Corporation Limited	Jiangmen Guangdong, China	Manufacturer	api.fda.gov
Sinntech Medical (private) Limited	Sialkot Punjab, Pakistan	Manufacturer	api.fda.gov
Sundex Corporation	Taipei, Taiwan	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Sunkiss Healthcare(zhejiang) Co., Ltd	HANGZHOU Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Suzhou Avon Textile Co., Ltd.	Suzhou City Jiangsu, China	Contract manufacturer	api.fda.gov
Suzhou Sunmed Co., Ltd	SUZHOU CITY Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Synopex Biofilter	Hwaseong-si Gyeonggi, South Korea	Contract manufacturer, Manufacturer	api.fda.gov
Scope Medical Devices Private Limited	Ambala City Haryana, India	Foreign private label distributor, Manufacturer, Repackager or relabeler	api.fda.gov
Simba Apparel EPZ LTD	Mombasa, Kenya	Contract manufacturer	api.fda.gov
Su Biyomedikal Sistemler Ve Saglik Hiz. San. ve Tic. A. S.	Tekirdag, Turkey	Contract manufacturer, Manufacturer	api.fda.gov
The Body Doctor Ltd	Park Mill Way, Clayton West Calderdale, United Kingdom	Manufacturer	api.fda.gov
Tianjin Tairuibosi Medical Appliance Co., Ltd.	Tianjin, China	Exporter to the US, Manufacturer	api.fda.gov
Tianjin Yiyi Hygiene Products Co.,ltd.	tianjin, China	Exporter to the US, Manufacturer	api.fda.gov
TVP Developments Ltd	Kowloon, Hong Kong	Exporter to the US, Specification developer	api.fda.gov
Two One Two New York, Inc.	Edgewood, NY, United States	Contract manufacturer, Manufacturer	api.fda.gov
Tsung Hau Technology Co., Ltd.	Kaohsiung City, Taiwan	Exporter to the US, Manufacturer	api.fda.gov
U-Join Company Limited	Yuanlin City Changhua, Taiwan	Manufacturer	api.fda.gov
U-Play Products Corporation	wuhu Anhui, China	Exporter to the US, Manufacturer	api.fda.gov
Ubiosis Co.,ltd.	Seongnam-si Gyeonggi, South Korea	Manufacturer	api.fda.gov
Vietnam Medical Plastic JSC	Tam Diep Ward Ninh Binh, Vietnam	Manufacturer	api.fda.gov
Vistar Medical Supplies Co., Ltd.	SHENZHEN Guangdong, China	Manufacturer	api.fda.gov
Wei Shi Hao Corporation	Taizhou City Zhejiang, China	Manufacturer	api.fda.gov
Weihai Dishang Medical Technology Co.,ltd	Weihai Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
Wen Zhou Jinda Imp&exp Co., Ltd	Wenzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Wenzhou Aie Industry And Trade Co., Ltd	Wenzhou Zhejiang, China	Manufacturer	api.fda.gov
Wenzhou Sanshan Optics Co., Ltd.	WENZHOU Zhejiang, China	Manufacturer	api.fda.gov
Winbest Biotech (thailand) Co. Ltd.	Ban Pho Chachoengsao, Thailand	Manufacturer	api.fda.gov
Wuhan Huawei Technology Co., Ltd	Wuhan Hubei, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Wuhan Lucky Star Non Woven Products Co Ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer, Repackager or relabeler	api.fda.gov
Wuhan Youfu International Trade Co.,ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Wuhan Zonsen Medical Products Co., Ltd	Wuhan Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Wellmed Dental Medical Supply Co., Ltd	Shenzhen Guangdong, China	Manufacturer	api.fda.gov
Wenzhou Shengkai Technology Industry Co.,Ltd	Wenzhou city Zhejiang, China	Manufacturer	api.fda.gov
Xiantao Daoqi Plastic Co., Ltd.	Xiantao Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Xiantao Generalcare Protection Products Co.,ltd	Xiantao City Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Xiantao Hooray Protective Products Co.,ltd	Xiantao City Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
Xiantao Junhui Plastic Products Co.,ltd.	Xiantao Hubei, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Xiantao Junlong Protective Products Co.,ltd	Xiantao Hubei, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Xiantao Kimberly Protective Products Co., Ltd	Xiantao Hubei, China	Manufacturer	api.fda.gov
Xiantao S&J Protective Products Co., Ltd	Xiantao Hubei, China	Exporter to the US, Manufacturer	api.fda.gov
XIANTAO XINFA PLASTIC PRODUCTS Co. LTD.	Xiantao City Hubei, China	Contract manufacturer, Manufacturer	api.fda.gov
Xiantao Xingrong Protective Products Co., Ltd.	Xiantao Hubei, China	Manufacturer	api.fda.gov
Xuzhou Full Sun Medical Products Ltd.	Pizhou Jiangsu, China	Manufacturer	api.fda.gov
Yancheng Huida Medical Instruments Co., Ltd	Yancheng Jiangsu, China	Contract manufacturer, Manufacturer	api.fda.gov
Yangzhou Haodi Articles Of Everyday Use Co., Ltd.	YANGZHOU Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Yangzhou Xinhua Brushes Co., Ltd.	YANGZHOU Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Yasco Enterprise Corp.	Chiayi County Chiayi(County), Taiwan	Exporter to the US, Manufacturer	api.fda.gov
Yearstar Healthcare Technology Co.,ltd	JIANGYIN Jiangsu, China	Exporter to the US, Manufacturer	api.fda.gov
Yiwu Ruoxuan Garment Co.,ltd	Jinhua Zhejiang, China	Manufacturer	api.fda.gov
Yiwu Ori-Power Medtech Co., Ltd.	YIWU Zhejiang, China	Manufacturer	api.fda.gov
Zhejiang Banghaoning Medical Supplies Co., Ltd	YiWu Zhejiang, China	Manufacturer	api.fda.gov
Zhejiang Bangli Medical Products Co., Ltd.	YONGKANG CITY Zhejiang, China	Manufacturer	api.fda.gov
Zhejiang Excellent United Medical Technology Co.,ltd	Jinhua Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zhejiang Headway Medical Equipment Co., Ltd.	Hangzhou City Zhejiang, China	Manufacturer	api.fda.gov
Zhejiang Lidesen Medical Instrument Co., Ltd	Hangzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Zhejiang Luyao Electronics Technology Co.,ltd	Wenzhou Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zhejiang Runlab Technology Co., Ltd.	Taizhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Zhongshan Chukuang Textile Co., Ltd.	Zhongshan City, Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	api.fda.gov
Zhuji Zhenguang Kniitting&textile Co.,ltd	Zhuji Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zibo Qichuang Medical Products Co.,ltd.	Zibo Shandong, China	Exporter to the US, Manufacturer	api.fda.gov
Zhangzhou iHastek Inc.	Zhangzhou City Fujian, China	Manufacturer	api.fda.gov
Zhejiang E-WAY Healthcare Co., Ltd.	Jiaxing Zhejiang, China	Exporter to the US, Manufacturer	api.fda.gov
Zhejiang Longterm Medical Technology Co., LTD	Huzhou City Zhejiang, China	Manufacturer	api.fda.gov

Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.