EU → North America Device Access

Albomed GmbH

DE-MF-000007875 · Germany · Schwarzenbruck

Albomed GmbH is registered in the European database on medical devices as a manufacturer, with 269 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb145
Class I124

Most frequent device types declared: HPMC Intra-Ocular Gel, Hyaluronate Intra-Articular Gel, Hyaluronate Intra-Articular-Max Gel, Pe-Ha-Guard, Sodium Hyaluronate Intra-Ocular Gel.

Among these devices, 269 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 269 declared devices.

Catalogue references include 03760, 03885, 04168, 04500, 04776, 04836.

European nomenclature codes declared: P900402, Q02030301, Q02030399.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED269
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN269
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. Albomed GmbH was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
D1478800027supplemented2031-04-20
D1478800026supplemented2027-02-17
D1478800025supplemented2031-04-20

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