EU → North America Device Access

SFM Hospital Products GmbH

DE-MF-000005505 · Germany · Berlin

SFM Hospital Products GmbH is registered in the European database on medical devices as a manufacturer, with 10 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa10

Most frequent device types declared: Untersuchungshandschuhe, unsteril, Nitril puderfrei.

Devices declared under this manufacturer

Catalogue references include Größe L, Größe M, Größe S, Größe XL, Größe XS, Größen: XS, S, M, L, XL, XXL.

European nomenclature codes declared: T01020204.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED10
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 GTIN10
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. SFM Hospital Products GmbH was not found in either the U.S. or the Canadian register.

Other manufacturers in Germany

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