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Data / Medical devices / Test, Opiates, Over The Counter / China

FDA-registered makers of Test, Opiates, Over The Counter in China: 22 establishments

22 establishments in China are registered with the FDA to make Test, Opiates, Over The Counter (product code NGL). 15 have a 510(k) clearance or PMA approval on file and 0 have a recall event. 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 makers of this device in ChinaWatch these makers
Device
Test, Opiates, Over The Counter
Product code
NGL
Country
China

Makers of Test, Opiates, Over The Counter in China

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Eterbio, Inc.Zhuhai Guangdong, ChinaManufacturer2November 20, 2024000api.fda.gov
Hangzhou Clongene Biotech Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer2November 8, 2024000api.fda.gov
Anhui Deepblue Medical Technology Co., Ltd.Hefei Anhui, ChinaManufacturer1April 15, 2025000api.fda.gov
Assure Tech. (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaComplaint file establishment, Manufacturer, Specification developer1March 6, 2024000api.fda.gov
Assure Tech. (Hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer1March 6, 2024000api.fda.gov
Co-Innovation Biotech Co.,ltd.Guangzhou Guangdong, ChinaContract manufacturer, Manufacturer1May 22, 2024000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer1July 16, 2024000api.fda.gov
Guangzhou Wondfo Biotech Co., Ltd.Dongguan Guangdong, ChinaManufacturer1July 16, 2024000api.fda.gov
Guangzhou Decheng Biotechnology Co., Ltd.Guangzhou Guangdong, ChinaComplaint file establishment, Manufacturer1February 6, 2025000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer1October 26, 2023000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer1October 26, 2023000api.fda.gov
Hangzhou AllTest Biotech Co.,LtdHangzhou Zhejiang, ChinaManufacturer1October 26, 2023000api.fda.gov
Qingdao Hightop Biotech Co., Ltd.Qingdao Shandong, ChinaManufacturer1August 14, 2024000api.fda.gov
Safecare Biotech(hangzhou)co.,ltdHuzhou Zhejiang, ChinaManufacturer1April 10, 2024000api.fda.gov
Vivachek Biotech (hangzhou) Co., LtdHangzhou, Zhuji Zhejiang, ChinaManufacturer1October 4, 2024000api.fda.gov
Abon Biopharm (hangzhou) Co., Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
Bioteke Corporation (wuxi) Co., LtdWuxi City Jiangsu, ChinaManufacturer0000api.fda.gov
Core Technology Co., Ltd.Changping District Beijing, ChinaContract manufacturer0000api.fda.gov
Hangzhou Aichek Medical Technology Co., Ltd.Hangzhou Zhejiang, ChinaManufacturer0000api.fda.gov
Hangzhou Biotest Biotech Co.,Ltd.Hangzhou Zhejiang, ChinaContract manufacturer0000api.fda.gov
W.H.P.M. Bioresearch & Technology Co., Ltd.Beijing, ChinaManufacturer0000api.fda.gov
Zhejiang Orient Gene BiotechHuzhou Zhejiang, ChinaContract manufacturer0000api.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.