EU → North America Device Access

Bohus BioTech AB

SE-MF-000037369 · Sweden · Strömstad

Bohus BioTech AB is registered in the European database on medical devices as a manufacturer, with 22 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb1
Class I21

Among these devices, 22 are declared sterile, 21 implantable.

Devices declared under this manufacturer

Showing 12 of 22 declared devices.

European nomenclature codes declared: P900402, Q02030301.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED22
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 GTIN22
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. Bohus BioTech AB was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
MDR 792676supplemented2031-03-30

Other manufacturers in Sweden

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