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Shenzhen Comen Medical Instruments Co.,LTD.

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

Registration number (SRN)CN-MF-000002236
RoleManufacturer
StatusActive
CountryChina
City518106 Shenzhen
AddressFloor 10, Floor 11 and Section C of Floor 12 of Building 1A & Floor 1 to Floor 5 of Building 2, FIYTA Timepiece Building, Nanhuan Avenue, Matian Sub-district, Guangming District, Shenzhen, Guangdong, 518106, P.R.China., 518106 Shenzhen
Registered on2021-03-18

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entrySHENZHEN COMEN MEDICAL INSTRUMENTS CO., LTD. (CN) · FDA 3008716327

Notified body certificates

CertificateStatusExpiryTypeBody
FI23/1008002supplemented2028-09-05Quality management systemNB 0598
CN24/00004079amended2029-07-01Quality assuranceNB 1639
CN23/00001577supplemented2028-03-31Quality management systemNB 1639

⚠️ 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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