Data / Medical devices / System, Test, Blood Glucose, Over The Counter / China
FDA-registered makers of System, Test, Blood Glucose, Over The Counter in China: 18 establishments
18 establishments in China are registered with the FDA to make System, Test, Blood Glucose, Over The Counter (product code NBW). 9 have a 510(k) clearance or PMA approval on file and 0 have a recall event. FDA data exported November 3, 2026.
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- Device
- System, Test, Blood Glucose, Over The Counter
- Product code
- NBW
- Country
- China
Makers of System, Test, Blood Glucose, Over The Counter in China
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Tianjin Empecs Medical Device Co., Ltd. | Tianjin, China | Manufacturer | 4 | June 7, 2017 | 0 | 0 | 0 | api.fda.gov |
| Dongguan Honfield Precision Parts Co., Ltd | Zhangmutou, Dongguan Guangdong, China | Contract manufacturer, Exporter to the US, Repackager or relabeler | 3 | March 23, 2018 | 0 | 0 | 0 | api.fda.gov |
| Guangdong Transtek Medical Electronics Co.,ltd | Zhongshan Guangdong, China | Exporter to the US, Manufacturer | 3 | January 30, 2025 | 0 | 0 | 0 | api.fda.gov |
| Vivachek Biotech (hangzhou) Co., Ltd | Hangzhou, Zhuji Zhejiang, China | Contract manufacturer, Manufacturer | 3 | August 16, 2024 | 0 | 0 | 0 | api.fda.gov |
| Andon Health Co., Ltd | Tianjin, China | Exporter to the US, Manufacturer, Specification developer | 2 | February 1, 2019 | 0 | 0 | 0 | api.fda.gov |
| Bioland Technology Ltd. | SHENZHEN Guangdong, China | Manufacturer | 2 | August 12, 2022 | 0 | 0 | 0 | api.fda.gov |
| Changsha Sinocare Inc. | Changsha Hunan, China | Manufacturer | 2 | December 1, 2023 | 0 | 0 | 0 | api.fda.gov |
| Microtech Medical (hangzhou) Co., Ltd. | Hangzhou Zhejiang, China | Complaint file establishment, Manufacturer | 1 | September 11, 2020 | 0 | 0 | 0 | api.fda.gov |
| Sejoy Biomedical Co., Ltd. | Hangzhou City Zhejiang, China | Manufacturer | 1 | October 8, 2024 | 0 | 0 | 0 | api.fda.gov |
| Acon Biotech (hangzhou) Co., Ltd. | HANGZHOU Zhejiang, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Altek Medical (kunshan) limited | Kunshan Free Trade Zone Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Andon Medical co., LTD | Tianjin, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Dongguan Kaifa Technology Co.,ltd. | Dongguan Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Medical Device Manufacturing (Shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Shenzhen Creative Industry Co., Ltd | SHENZHEN Guangdong, China | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Sanmina | Kunshan Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Yasee Biomedical Inc | QINGDAO Shandong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 3, 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.