EU → North America Device Access

AB Germa

SE-MF-000003932 · Sweden · Kristianstad

AB Germa is registered in the European database on medical devices as a manufacturer, with 427 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa427

Devices declared under this manufacturer

Showing 12 of 427 declared devices.

Catalogue references include 14005002021, 23005001001, 23271000740, 23271404000, 23271504000, 23272801000.

European nomenclature codes declared: V0804, V080505, V0899, V0299.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED427
Country of registrationSweden

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

Device-level evidence

Devices with a numeric GTIN427
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. AB Germa was not found in either the U.S. or the Canadian register.

Other manufacturers in Sweden

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