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Henan Tuoren Kingtaek Medical Device Co., Ltd.

Manufacturer of medical devices registered in the European database in Changyuan County, Henan Province, China.

Registration number (SRN)CN-MF-000015021
RoleManufacturer
StatusActive
CountryChina
City453400 Changyuan County, Henan Province
AddressWeiqi Road Central, Weiqi Road Central 453400 Changyuan County, Henan Province
Registered on2021-10-25

United States market access

FDA establishment register Not found in the U.S. FDA register

⚠️ Not found is not the same as not registered. The two registers share no common identifier; the comparison is made on company names. This manufacturer may reach the United States through a distributor, or be registered under a name we could not match. State of the FDA register on 2026-08-20.

Notified body certificates

CertificateStatusExpiryTypeBody
M.2025.MDR.1064cancelled2030-02-25Quality management systemNB 2696
G10 003954 0004cancelled2028-08-07Quality management systemNB 0123

⚠️ 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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