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
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Promisemed Hangzhou Meditech Co.,ltd. | Hangzhou Zhejiang, China | Contract manufacturer, Exporter to the US, Manufacturer | 12 | April 16, 2026 | 0 | 0 | 0 | api.fda.gov |
| Berpu Medical Technology Co., Ltd. | WENZHOU Zhejiang, China | Contract manufacturer, Manufacturer | 4 | February 1, 2024 | 0 | 0 | 0 | api.fda.gov |
| Tianjin Huahong Technology Co., Ltd. | Tianjin, China | Manufacturer | 4 | August 10, 2026 | 0 | 0 | 0 | api.fda.gov |
| Zhejiang Kindly Medical Devices Co., Ltd | WENZHOU Zhejiang, China | Contract manufacturer, Contract sterilizer, Manufacturer | 4 | December 12, 2023 | 0 | 1 | 0 | api.fda.gov |
| Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | Taihu Anhui, China | Exporter to the US, Manufacturer | 3 | September 20, 2023 | 0 | 0 | 0 | api.fda.gov |
| Sandstone Medical (suzhou) Inc. | Suzhou Jiangsu, China | Manufacturer | 3 | March 25, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shandong Caremed Medical Products Co.,ltd. | Heze Shandong, China | Exporter to the US, Manufacturer | 3 | March 7, 2016 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Carelife International Trading Co. Ltd | Jinqiao Pudong Shanghai, China | Exporter to the US, Specification developer | 3 | August 11, 2015 | 0 | 0 | 0 | api.fda.gov |
| Anhui Tiankang Medical Technology Co., Ltd. | Tianchang Anhui, China | Manufacturer | 2 | August 6, 2020 | 0 | 0 | 0 | api.fda.gov |
| Hantech Medical Device Co., Ltd. | Cixi Zhejiang, China | Manufacturer | 2 | April 6, 2023 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Caina Medical Co., Ltd | Jiangyin Jiangsu, China | Contract manufacturer, Manufacturer | 2 | June 2, 2023 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Medsun Medical Co., Ltd. | Ningbo Zhejiang, China | Manufacturer | 2 | March 18, 2026 | 0 | 0 | 0 | api.fda.gov |
| Shanghai Kindly Enterprise Development Group Co., Ltd. | JIADING Shanghai, China | Exporter to the US, Manufacturer, Specification developer | 2 | December 12, 2023 | 0 | 0 | 0 | api.fda.gov |
| Wuxi Yushou Medical Appliances Co., Ltd | Wuxi City Jiangsu, China | Contract manufacturer, Manufacturer | 2 | November 20, 2013 | 0 | 0 | 0 | api.fda.gov |
| Guangzhou Improve Medical Instruments Co., Ltd. | Guangzhou Guangdong, China | Manufacturer | 1 | June 7, 2016 | 0 | 3 | 0 | api.fda.gov |
| Gemtier Medical (Shanghai) Inc. | Shanghai, China | Manufacturer | 1 | December 11, 2017 | 0 | 0 | 0 | api.fda.gov |
| Hangzhou Qiantang Longyue Biotechnology Co.,Ltd | Hangzhou Zhejiang, China | Manufacturer | 1 | August 7, 2026 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Micsafe Medical Technology Co., Ltd | Yancheng Jiangsu, China | Manufacturer | 1 | May 14, 2018 | 0 | 0 | 0 | api.fda.gov |
| Jiangsu Shenli Medical Production Co.,ltd | CHANGZHOU Jiangsu, China | Manufacturer | 1 | March 14, 2017 | 0 | 0 | 0 | api.fda.gov |
| Ningbo Caremed Medical Products Co Ltd | Ningbo Zhejiang, China | Manufacturer | 1 | May 29, 2014 | 0 | 0 | 0 | api.fda.gov |
| Nipro (shanghai) Co., Ltd. | Shanghai, China | Manufacturer | 1 | November 10, 2005 | 0 | 0 | 0 | api.fda.gov |
| Sterilance Medical (Suzhou) Inc. | Suzhou Jiangsu, China | Manufacturer | 1 | August 29, 2016 | 0 | 0 | 0 | api.fda.gov |
| Weihai Hongyu Medical Devices Co., Ltd. | Weihai Shandong, China | Manufacturer | 1 | April 6, 2011 | 0 | 0 | 0 | api.fda.gov |
| Zhangzhou Aoxi Plastic Co., Ltd. | ZHANGZHOU Fujian, China | Exporter to the US, Manufacturer | 1 | April 17, 2006 | 0 | 0 | 0 | api.fda.gov |
| embecta Medical Devices (Suzhou) Co., Ltd. | Suzhou Jiangsu, China | Manufacturer | 1 | June 28, 2022 | 0 | 0 | 0 | api.fda.gov |
| Aena Medical (jiangsu) Co.,ltd. | Jiangyin City Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Amsino Medical (kunshan) Co., Ltd. | KUNSHAN CITY Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Anhui Kangda Medical Products Co., Ltd. | Tianchang City Anhui, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Arrow Medsource Group Limited | Hongkong, China | Exporter to the US, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Chengdu Xinjin Shifeng Medical Apparatus & Instrument Co., Ltd. | Chengdu Sichuan, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Duopross Meditech (Kunshan) Co., Ltd. | Kunshan Jiangsu, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Hantech (ningbo) Medical Technology Co., Ltd. | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Kangbao Medical Equipment Co., Ltd | Yangzhou Jiangsu, China | Contract manufacturer, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Rongye Technology Co.,ltd | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangsu Zhiyu Medical Instrument Co., Ltd | West Taixing City Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Hongda Medical Equipment Group Ltd. | Nanchang Jiangxi, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jiangxi Sanxin Medtec Co.,ltd. | Nanchang Jiangxi, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Jumin Bio-Technologies, Co., Ltd | Fengxian District Shanghai, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ningbo Risenmed Technology Co.,ltd. | Ningbo Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Zhushi Pharmaceutical Group Co., Ltd | Heze Shandong, China | Exporter to the US, Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shanghai Kohope Medical Devices Co., Ltd | Shanghai, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shantou Wealy Medical Instrument Co., Ltd. | SHANTOU Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Hys Medical Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sol-Kl (shanghai) Medical Products Company Limited | Shanghai, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shandong Ande Healthcare Apparatus Co., Ltd. | Zibo Shandong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Winner Medical (hunan) Co., Ltd. | Changde Hunan, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yangzhou Medline Industry Co., Ltd. | Yangzhou Jiangsu, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Ini Medical Devices Co., Ltd | WENZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhejiang Kangkang Medical-Devices Co., Ltd. | Taizhou Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ZHEJIANG LONGDE PHARMACEUTICAL Co., Ltd | HANGZHOU Zhejiang, China | Contract manufacturer, Contract sterilizer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zhuhai DR Medical Instruments Co., Ltd. | Zhuhai Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | 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.