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Data / Medical devices / Needle, Hypodermic, Single Lumen / China

FDA-registered makers of Needle, Hypodermic, Single Lumen in China: 51 establishments

51 establishments in China are registered with the FDA to make Needle, Hypodermic, Single Lumen (product code FMI). 25 have a 510(k) clearance or PMA approval on file and 2 have a recall event. FDA data exported November 2, 2026.

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Device
Needle, Hypodermic, Single Lumen
Product code
FMI
Country
China

Makers of Needle, Hypodermic, Single Lumen in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Promisemed Hangzhou Meditech Co.,ltd.Hangzhou Zhejiang, ChinaContract manufacturer, Exporter to the US, Manufacturer12April 16, 2026000api.fda.gov
Berpu Medical Technology Co., Ltd.WENZHOU Zhejiang, ChinaContract manufacturer, Manufacturer4February 1, 2024000api.fda.gov
Tianjin Huahong Technology Co., Ltd.Tianjin, ChinaManufacturer4August 10, 2026000api.fda.gov
Zhejiang Kindly Medical Devices Co., LtdWENZHOU Zhejiang, ChinaContract manufacturer, Contract sterilizer, Manufacturer4December 12, 2023010api.fda.gov
Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd.Taihu Anhui, ChinaExporter to the US, Manufacturer3September 20, 2023000api.fda.gov
Sandstone Medical (suzhou) Inc.Suzhou Jiangsu, ChinaManufacturer3March 25, 2026000api.fda.gov
Shandong Caremed Medical Products Co.,ltd.Heze Shandong, ChinaExporter to the US, Manufacturer3March 7, 2016000api.fda.gov
Shanghai Carelife International Trading Co. LtdJinqiao Pudong Shanghai, ChinaExporter to the US, Specification developer3August 11, 2015000api.fda.gov
Anhui Tiankang Medical Technology Co., Ltd.Tianchang Anhui, ChinaManufacturer2August 6, 2020000api.fda.gov
Hantech Medical Device Co., Ltd.Cixi Zhejiang, ChinaManufacturer2April 6, 2023000api.fda.gov
Jiangsu Caina Medical Co., LtdJiangyin Jiangsu, ChinaContract manufacturer, Manufacturer2June 2, 2023000api.fda.gov
Ningbo Medsun Medical Co., Ltd.Ningbo Zhejiang, ChinaManufacturer2March 18, 2026000api.fda.gov
Shanghai Kindly Enterprise Development Group Co., Ltd.JIADING Shanghai, ChinaExporter to the US, Manufacturer, Specification developer2December 12, 2023000api.fda.gov
Wuxi Yushou Medical Appliances Co., LtdWuxi City Jiangsu, ChinaContract manufacturer, Manufacturer2November 20, 2013000api.fda.gov
Guangzhou Improve Medical Instruments Co., Ltd.Guangzhou Guangdong, ChinaManufacturer1June 7, 2016030api.fda.gov
Gemtier Medical (Shanghai) Inc.Shanghai, ChinaManufacturer1December 11, 2017000api.fda.gov
Hangzhou Qiantang Longyue Biotechnology Co.,LtdHangzhou Zhejiang, ChinaManufacturer1August 7, 2026000api.fda.gov
Jiangsu Micsafe Medical Technology Co., LtdYancheng Jiangsu, ChinaManufacturer1May 14, 2018000api.fda.gov
Jiangsu Shenli Medical Production Co.,ltdCHANGZHOU Jiangsu, ChinaManufacturer1March 14, 2017000api.fda.gov
Ningbo Caremed Medical Products Co LtdNingbo Zhejiang, ChinaManufacturer1May 29, 2014000api.fda.gov
Nipro (shanghai) Co., Ltd.Shanghai, ChinaManufacturer1November 10, 2005000api.fda.gov
Sterilance Medical (Suzhou) Inc.Suzhou Jiangsu, ChinaManufacturer1August 29, 2016000api.fda.gov
Weihai Hongyu Medical Devices Co., Ltd.Weihai Shandong, ChinaManufacturer1April 6, 2011000api.fda.gov
Zhangzhou Aoxi Plastic Co., Ltd.ZHANGZHOU Fujian, ChinaExporter to the US, Manufacturer1April 17, 2006000api.fda.gov
embecta Medical Devices (Suzhou) Co., Ltd.Suzhou Jiangsu, ChinaManufacturer1June 28, 2022000api.fda.gov
Aena Medical (jiangsu) Co.,ltd.Jiangyin City Jiangsu, ChinaContract manufacturer0000api.fda.gov
Amsino Medical (kunshan) Co., Ltd.KUNSHAN CITY Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Anhui Kangda Medical Products Co., Ltd.Tianchang City Anhui, ChinaContract manufacturer0000api.fda.gov
Arrow Medsource Group LimitedHongkong, ChinaExporter to the US, Specification developer0000api.fda.gov
Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd.Chengdu Sichuan, ChinaContract manufacturer0000api.fda.gov
Duopross Meditech (Kunshan) Co., Ltd.Kunshan Jiangsu, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Hantech (ningbo) Medical Technology Co., Ltd.Ningbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Jiangsu Kangbao Medical Equipment Co., LtdYangzhou Jiangsu, ChinaContract manufacturer, Manufacturer0000api.fda.gov
Jiangsu Rongye Technology Co.,ltdYangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangsu Zhiyu Medical Instrument Co., LtdWest Taixing City Jiangsu, ChinaManufacturer0000api.fda.gov
Jiangxi Hongda Medical Equipment Group Ltd.Nanchang Jiangxi, ChinaManufacturer0000api.fda.gov
Jiangxi Sanxin Medtec Co.,ltd.Nanchang Jiangxi, ChinaExporter to the US, Manufacturer0000api.fda.gov
Jumin Bio-Technologies, Co., LtdFengxian District Shanghai, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Ningbo Risenmed Technology Co.,ltd.Ningbo Zhejiang, ChinaContract manufacturer0000api.fda.gov
Shandong Zhushi Pharmaceutical Group Co., LtdHeze Shandong, ChinaExporter to the US, Manufacturer0000api.fda.gov
Shanghai Kohope Medical Devices Co., LtdShanghai, ChinaManufacturer0000api.fda.gov
Shantou Wealy Medical Instrument Co., Ltd.SHANTOU Guangdong, ChinaManufacturer0000api.fda.gov
Shenzhen Hys Medical Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Sol-Kl (shanghai) Medical Products Company LimitedShanghai, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Shandong Ande Healthcare Apparatus Co., Ltd.Zibo Shandong, ChinaManufacturer0000api.fda.gov
Winner Medical (hunan) Co., Ltd.Changde Hunan, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Yangzhou Medline Industry Co., Ltd.Yangzhou Jiangsu, ChinaManufacturer0000api.fda.gov
Zhejiang Ini Medical Devices Co., LtdWENZHOU Zhejiang, ChinaContract manufacturer0000api.fda.gov
Zhejiang Kangkang Medical-Devices Co., Ltd.Taizhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
ZHEJIANG LONGDE PHARMACEUTICAL Co., LtdHANGZHOU Zhejiang, ChinaContract manufacturer, Contract sterilizer0000api.fda.gov
Zhuhai DR Medical Instruments Co., Ltd.Zhuhai Guangdong, ChinaManufacturer0000api.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.