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EXBIO Praha, a.s.

Manufacturer of medical devices registered in the European database in Vestec, Czechia.

Registration number (SRN)CZ-MF-000033468
RoleManufacturer
StatusActive
CountryCzechia
City25250 Vestec
AddressNad Safinou II, 341 25250 Vestec
Registered on2023-02-14

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryEXBIO PRAHA, A.S. (CZ) · FDA 3008794764

Notified body certificates

CertificateStatusExpiryTypeBody
2025-IVDR/QS-002valid2029-06-11Quality management systemNB 2265
2024-IVDR/QS-004supplemented2029-06-11Quality management systemNB 2265

⚠️ 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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