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BIOTRONIK SE & Co. KG

Manufacturer of medical devices registered in the European database in Berlin, Germany.

Registration number (SRN)DE-MF-000005049
Short nameBIOTRONIK
RoleManufacturer
StatusActive
CountryGermany
City12359 Berlin
AddressWoermannkehre, 1 12359 Berlin
Registered on2021-05-26

United States market access

FDA establishment register Registered with the U.S. FDA
Matched entryBIOTRONIK SE & CO. KG (DE) · FDA 9610139

Notified body certificates

CertificateStatusExpiryTypeBody
G70 010275 0541validexpired 2026-08-05Technical documentationNB 0123
20363GB448260407amended2027-09-28Quality management systemNB 0482
20363GB448250929valid2027-09-28Quality management systemNB 0482
13290GB450230504Avalid2028-02-20Technical documentationNB 0482

⚠️ 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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