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HangZhou Biotest  Biotech Co.,Ltd.

Manufacturer of medical devices registered in the European database in Hangzhou, China.

Registration number (SRN)CN-MF-000008191
RoleManufacturer
StatusActive
CountryChina
City311121 Hangzhou
Address17 Futai Road, Zhongtai Street, Yuhang District, 311121 Hangzhou
Registered on2021-06-24

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryHangzhou Biotest Biotech Co.,Ltd. (CN) · FDA 3011522054

Notified body certificates

CertificateStatusExpiryTypeBody
EU-QMS-FI-72717-800073-2026valid2031-02-03Quality management systemNB 3018

⚠️ State of the register on 2026-08-20. EUDAMED shows only the current version of a certificate — earlier versions are not published, by the Commission or by anyone. A certificate shown as valid here may have changed since. For a legally binding check, consult EUDAMED directly.

The SRN is the registration number assigned by the European Commission. It has been mandatory since 28 May 2026 for any operator placing a medical device on the Union market. Contact details are published in the official register; we do not reproduce them here.

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