Data / Medical devices / Light, Examination, Medical, Battery Powered

Light, Examination, Medical, Battery Powered (KYT): 126 FDA-registered makers in 22 countries

Name: FDA-registered makers of Light, Examination, Medical, Battery Powered
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

126 establishments in 22 countries are registered with the FDA to make Light, Examination, Medical, Battery Powered (product code KYT, Class 1, 21 CFR 880.6350). 0 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 6 510(k) clearances under this code, the latest on March 27, 1992, and lists 1 recall event (0 Class I). FDA data exported November 2, 2026.

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Product code: KYT
Device class: 1
Regulation: 880.6350
Medical specialty: General Hospital

Makers by country

Country	Makers
China	44
United States	31
Germany	9
South Korea	7
Pakistan	6
Taiwan	3
India	3
Canada	3
France	3
Israel	2
Mexico	2
Vietnam	2
Australia	2
Singapore	1
Argentina	1
Denmark	1
Philippines	1
Malaysia	1
Hong Kong	1
Japan	1
Italy	1
Indonesia	1

Makers of Light, Examination, Medical, Battery Powered

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	Recall events	Source
Admetec Solution Ltd	Haifa, Israel	Manufacturer	0	api.fda.gov
Aesculap AG	TUTTLINGEN, DONAU Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
Aid United International Co., Limited	Shanghai, China	Exporter to the US, Repackager or relabeler, Specification developer	0	api.fda.gov
Aiobio Co., Ltd.	Seongnam-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
American Diagnostic Corp.	Hauppauge, NY, United States	Manufacturer, Repackager or relabeler	0	api.fda.gov
Ari Medical Technology Co., Ltd.	Hefei Anhui, China	Manufacturer	0	api.fda.gov
Aspen Surgical Products, Inc.	Caledonia, MI, United States	Complaint file establishment, Specification developer	0	api.fda.gov
Belletorus Corporation	Cambridge, MA, United States	Repackager or relabeler, Specification developer	0	api.fda.gov
Bionix, LLC	Maumee, OH, United States	Manufacturer	0	api.fda.gov
Boen Healthcare Co., Ltd.	Suzhou Jiangsu, China	Exporter to the US, Specification developer	0	api.fda.gov
Bothwin Medical Technology (SG) Pte. Ltd.	Singapore Central Singapore, Singapore	Specification developer	0	api.fda.gov
Beaver-Visitec International, Inc.	Waltham, MA, United States	Specification developer	0	api.fda.gov
Beaver-Visitec International, Inc.	Ciudad Juarez Chihuahua, Mexico	Contract manufacturer	0	api.fda.gov
Bistos co., ltd.	Yongin-si Gyeonggi, South Korea	Complaint file establishment, Manufacturer	0	api.fda.gov
Bothwin (Beijing) Medical Technology Co., Ltd.	Beijng Beijing, China	Manufacturer	0	api.fda.gov
Canfield Scientific, Inc.	Parsippany, NJ, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Carl Zeiss Meditec AG (jena)	JENA Thuringia, Germany	Specification developer	0	api.fda.gov
Ceek Women's Health	Portland, OR, United States	Specification developer	0	api.fda.gov
Central Surgical Co. Pvt. Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
Chin Kou Medical Instrument Co.,ltd.	New Taipei City, Taiwan	Manufacturer	0	api.fda.gov
Den-Mat Holdings, LLC	Lompoc, CA, United States	Complaint file establishment, Manufacturer	0	api.fda.gov
Dentlight Inc.	Plano, TX, United States	Manufacturer	0	api.fda.gov
Dentozone Corporation	Guro-gu Seoul, South Korea	Manufacturer	0	api.fda.gov
Dien Quang High Tech Company Limited	Ho Chi Minh, Vietnam	Contract manufacturer	0	api.fda.gov
Doctor Devices	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
Dongguan I-Believe Electronic Appliance Co., Ltd.	DongGuan Guangdong, China	Manufacturer	0	api.fda.gov
DermLite LLC	Aliso Viejo, CA, United States	Manufacturer	1	api.fda.gov
Dongguan City Ruimi Gift Products Co Ltd	Dongguan Guangdong, China	Exporter to the US, Manufacturer	0	api.fda.gov
Dr. Mach GmbH & Co. KG	Grafing Bavaria, Germany	Manufacturer	0	api.fda.gov
Easy-Rn, LLC	Coral Springs, FL, United States	Remanufacturer	0	api.fda.gov
Ecleris SRL	Villa Martelli Buenos Aires, Argentina	Specification developer	0	api.fda.gov
Endonest Medical Systems LLP	PALGHAR Maharashtra, India	Manufacturer	0	api.fda.gov
Eusa Global LLC	Medley, FL, United States	Contract manufacturer	0	api.fda.gov
Examvision A/S	samsoe Midtjylland, Denmark	Manufacturer	0	api.fda.gov
Fenghua Tealmed Emergency Products Co.,ltd.	Ningbo Zhejiang, China	Manufacturer	0	api.fda.gov
Firefly Global	Belmont, MA, United States	Manufacturer	0	api.fda.gov
Firefly Vein Light LLC	Chattanooga, TN, United States	Specification developer	0	api.fda.gov
Forward Science Technologies LLC	Houston, TX, United States	Manufacturer	0	api.fda.gov
Falcon Surgical Co. (Pvt.) Ltd.	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
General Scientific Corp.	Ann Arbor, MI, United States	Manufacturer	0	api.fda.gov
Good Doctors Co., Ltd.	Incheon Seoul, South Korea	Manufacturer	0	api.fda.gov
Guilin Kevin Peter Technology Co., Ltd.	Guilin Guangxi, China	Manufacturer	0	api.fda.gov
Hangzhou Aosi Healthcare Co., Ltd.	HANGZHOU Zhejiang, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Happersberger Otopront GMBH	Hohenstein Hesse, Germany	Manufacturer	0	api.fda.gov
Hazel Enterprises	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
Hefei MT Medical Co.,ltd.	Hefei Anhui, China	Exporter to the US, Manufacturer	0	api.fda.gov
Heine Optotechnik GMBH & Co. KG.	GILCHING Bavaria, Germany	Manufacturer	0	api.fda.gov
Hi-Tech Electronics	Oglesby, IL, United States	Contract manufacturer	0	api.fda.gov
Hoang Nguyen Health Services Equipment Manufacture And Trading Company Limited	Ly Thuong Kiet Ward Ninh Binh, Vietnam	Manufacturer	0	api.fda.gov
Illuco Co, Ltd	Gumpo-si Gyeonggi, South Korea	Manufacturer	0	api.fda.gov
Impact Innovations LLC	Boca Raton, FL, United States	Specification developer	0	api.fda.gov
Industrias Apson S.A de C.V	AGUA PRIETA Sonora, Mexico	Contract manufacturer	0	api.fda.gov
Ionics EMS Inc.	Cabuyao City Laguna, Philippines	Contract manufacturer	0	api.fda.gov
Jiang Xi Big Vision Medical Technology Co.,ltd	Ganzhou Jiangxi, China	Manufacturer	0	api.fda.gov
Jiangsu Rooe Medical Technology Co., Ltd.	Zhangjiagang City Jiangsu, China	Exporter to the US, Manufacturer	0	api.fda.gov
Led Dental Inc.	Vancouver British Columbia, Canada	Specification developer	0	api.fda.gov
Little Doctor Electronic(nantong) Co.,ltd	Nantong Jiangsu, China	Specification developer	0	api.fda.gov
LKL Advance Metaltech Sdn Bhd	Seri Kembangan Selangor, Malaysia	Manufacturer	0	api.fda.gov
Long Island Technology Group LLC	Woodbury, NY, United States	Contract manufacturer, Manufacturer	0	api.fda.gov
Lumadent Inc	Reno, NV, United States	Manufacturer	0	api.fda.gov
Linvatec Corporation	Largo, FL, United States	Manufacturer	0	api.fda.gov
Macquarie Medical Systems Pvt. Ltd	Leichhardt New South Wales, Australia	Manufacturer, Repackager or relabeler	0	api.fda.gov
Madina Surgical Works	Sialkot Punjab, Pakistan	Manufacturer	0	api.fda.gov
MDF Instruments Medifriend Inc.	Song Jiang District, Shanghai, China	Manufacturer	0	api.fda.gov
Medimaging Integrated Solution Inc.	Hsinchu Hsinchu(City), Taiwan	Manufacturer	0	api.fda.gov
Medipia Co., Ltd.	Daegu, South Korea	Manufacturer	0	api.fda.gov
Medsource Factory,inc.	CHANGZHOU Jiangsu, China	Manufacturer	0	api.fda.gov
Metaoptima Technology Inc.	Vancouver British Columbia, Canada	Manufacturer	0	api.fda.gov
Modern Medical Equipment Manufacturing (qing Yuan) Ltd	QING YUAN Guangdong, China	Contract manufacturer, Contract sterilizer	0	api.fda.gov
Modern Medical Equipment Manufacturing Ltd.	HENG LI, DONGGUAN Guangdong, China	Contract manufacturer	0	api.fda.gov
Modern Medical Equipment Manufacturing, Ltd.	Kwai Chung, N.T., Hong Kong	Manufacturer	0	api.fda.gov
Medical Illumination International, Inc	Chatsworth, CA, United States	Manufacturer	0	api.fda.gov
Nanjing Yameng Intelligent Technology Co., Ltd	Nanjing Jiangsu, China	Manufacturer	0	api.fda.gov
Narang Medical, Ltd.	New Delhi, India	Manufacturer	0	api.fda.gov
Neitz Instruments Company, Ltd.	CHIYODA-KU Tokyo, Japan	Manufacturer	0	api.fda.gov
Ningbo Greetmed Medical Instruments Co., Ltd.	Ningbo Zhejiang, China	Exporter to the US, Specification developer	0	api.fda.gov
Ningbo Haishu Haoxin Medical Instrument Co., Ltd.	Ningbo Zhejiang, China	Manufacturer	0	api.fda.gov
Ningbo Ningyuan Import & Export Co., Ltd.	Ningbo, Zhejiang, China	Contract manufacturer, Manufacturer	0	api.fda.gov
Ningbo Risenmed Technology Co.,ltd.	Ningbo Zhejiang, China	Manufacturer	0	api.fda.gov
Ningbo Shun Ye Medical Company, Ltd.	Cixi Ningbo Zhejiang, China	Manufacturer	0	api.fda.gov
Ningbo Tianbo First Aid Product Co., Ltd.	Ningbo Zhejiang, China	Manufacturer	0	api.fda.gov
Ningbo Yongjin Medical Instruments Manufacture Co., Ltd.	Ningbo Zhejiang, China	Manufacturer	0	api.fda.gov
Nopa Instruments, Medizintechnik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0	api.fda.gov
North American Rescue, LLC.	Greer, SC, United States	Manufacturer	0	api.fda.gov
Ningbo Jiangbei Tenso Medical Instruments Co., Ltd	NINGBO Zhejiang, China	Manufacturer	0	api.fda.gov
Onlycare Inc	Denver, CO, United States	Manufacturer	0	api.fda.gov
Quality Aspirators, Inc.	Dallas, TX, United States	Manufacturer	0	api.fda.gov
Quality Aspirators, Inc.	Duncanville, TX, United States	Manufacturer	0	api.fda.gov
Quantel Medical	COURNON AUVERGNE Puy-de-Dome, France	Repackager or relabeler, Specification developer	0	api.fda.gov
Rudolf Riester GMBH	JUNGINGEN Baden-Wurttemberg, Germany	Manufacturer	0	api.fda.gov
Ruian Sunnyworld International Trade Co.,ltd	RUIAN Zhejiang, China	Manufacturer	0	api.fda.gov
RZ Medizintechnik GMBH	TUTTLINGEN Baden-Wurttemberg, Germany	Contract manufacturer	0	api.fda.gov
S.I.M.E.O.N. MEDICAL GMBH & Co.KG	TUTTLINGEN Baden-Wurttemberg, Germany	Complaint file establishment, Manufacturer	0	api.fda.gov
SBM Sistemi SRL	Rivalta di Torino, Italy	Manufacturer	0	api.fda.gov
Scan Optics Pty., Ltd.	THEBARTON, ADELAIDE South Australia, Australia	Manufacturer	0	api.fda.gov
Sedatelec	IRIGNY Rhone, France	Manufacturer	0	api.fda.gov
Shanghai Fly Medical Devices Co., Ltd.	Minhang District Shanghai, China	Manufacturer	0	api.fda.gov
Shanghai Link Instruments Co.,ltd	Changzhou City Jiangsu, China	Manufacturer	0	api.fda.gov
Shanghai May Skin Information Technology Co., Ltd.	Shanghai, China	Exporter to the US, Manufacturer	0	api.fda.gov
Shenzhen Iboolo Optics Co., Ltd.	Shenzhen Guangdong, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Skinlens LLC	St Petersburg, FL, United States	Manufacturer	0	api.fda.gov
Squaremind	Paris, France	Complaint file establishment, Manufacturer	0	api.fda.gov
Sugih Instrumendo Abadi, PT	Bandung Barat Jawa Barat, Indonesia	Manufacturer	0	api.fda.gov
Suzhou Pipi Medical Products Co.,ltd	Suzhou Jiangsu, China	Exporter to the US, Manufacturer	0	api.fda.gov
Shanghai Caremate Medical Device Co. Ltd	Shanghai, China	Manufacturer	0	api.fda.gov
Shenzhen Kaiyan Medical Equipment Co., Ltd	Shenzhen Guangdong, China	Manufacturer	0	api.fda.gov
Suzhou Meccan Import and Export Corp.	Suzhou Jiangsu, China	Manufacturer, Specification developer	0	api.fda.gov
Tech4life Enterprises Canada Inc	Oakville Ontario, Canada	Manufacturer	0	api.fda.gov
Translite	Sugar Land, TX, United States	Manufacturer, Specification developer	0	api.fda.gov
Tytocare Ltd.	Netanya Central, Israel	Manufacturer	0	api.fda.gov
Ultralight Optics Inc.	Westminster, CA, United States	Manufacturer	0	api.fda.gov
United Poly Engineering Pvt. Ltd.	New Delhi, India	Manufacturer	0	api.fda.gov
Utah Medical Products, Inc.	Midvale, UT, United States	Manufacturer	0	api.fda.gov
Valentine Intl. Ltd.	Hsichih City, Taipei Hsien, Taiwan	Exporter to the US, Manufacturer	0	api.fda.gov
Visuscience Meditech Co., Ltd.	WUXI Jiangsu, China	Manufacturer	0	api.fda.gov
Washington Surgical International	SIALKOT Punjab, Pakistan	Manufacturer	0	api.fda.gov
Wenzhou Caretek Medical Device Co., Ltd	Wenzhou Zhejiang, China	Exporter to the US, Manufacturer	0	api.fda.gov
Wenzhou Longwan Medical Device Factory	Wenzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Wenzhou Renhua Instruments Co.,ltd	WENZHOU Zhejiang, China	Manufacturer	0	api.fda.gov
Wenzhou Kangju Medical Instrument Co., Ltd.	Wenzhou Zhejiang, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Xemax Surgical Products, Inc.	Napa, CA, United States	Specification developer	0	api.fda.gov
Xenosys Co., Ltd.	Incheon, South Korea	Manufacturer	0	api.fda.gov
Yancheng Trancom First Aid Supplies Industrial Co., Ltd	Yangcheng Jiangsu, China	Contract manufacturer, Exporter to the US, Manufacturer	0	api.fda.gov
Zhejiang Fude Medphotonic Co.,ltd.	Huzhou City Zhejiang, China	Manufacturer	0	api.fda.gov
Zhejiang Mediunion Healthcare Group Co.,ltd	Ningbo Zhejiang, China	Manufacturer	0	api.fda.gov
Zumax Medical Co, Ltd.	Suzhou,Jiangsu, China	Manufacturer	0	api.fda.gov

Updated March 27, 1992. 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.