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MAI Medical EU GmbH

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

Registration number (SRN)DE-MF-000048879
RoleManufacturer
StatusActive
CountryGermany
City66649 Oberthal
AddressMühlenweg, 3 66649 Oberthal
Registered on2025-07-29

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

No certificate is recorded for this operator in the capture of 2026-08-20. ⚠️ This is not evidence that none exists. Only 3 114 of the 48 893 registered operators carry a certificate in EUDAMED — importers, distributors and authorised representatives never do, and a manufacturer's notified body may simply not have filed one yet.

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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