EU → US 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: Hyaluronate Intra-Articular Gel, Sodium Hyaluronate Intra-Ocular Gel, HPMC Intra-Ocular Gel, Hyaluronate Intra-Articular-Max Gel, Pe-Ha-Guard.

Among these devices, 269 are declared sterile.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED269
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

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

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