EU → North America Device Access

RFSU AB

SE-MF-000008574 · Sweden · Stockholm

RFSU AB is registered in the European database on medical devices as a manufacturer, with 101 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb101

Devices declared under this manufacturer

Showing 12 of 101 declared devices.

Catalogue references include 07310570100257, 07310571000631, 07310571000648, 07310571000839, 07310571000976, 07310573000271.

European nomenclature codes declared: U110101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED101
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 GTIN101
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. RFSU AB was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
28620129092-01issued2027-03-08

Other manufacturers in Sweden

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