EU → North America Device Access

Dr. Arabin GmbH & Co. KG

DE-MF-000005474 · Germany · Witten

Dr. Arabin GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 155 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa143
Class IIb12

Most frequent device types declared: Cerclage Pessar perforiert, Dr. Arabin Hybrid Pessare, Handgefertigte Pessare, Pessare mit Vakuumeffekt, Ringförmige Pessare.

Among these devices, 143 are declared reusable.

Catalogue references include HP 055, HP 085, KP 075, SSP 060, TP2+1 F2, TP4+5 F4.

European nomenclature codes declared: U089005.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED155
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 GTIN155
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. Dr. Arabin GmbH & Co. KG was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
1340GB448241217issued2028-07-02

Other manufacturers in Germany

All Germany manufacturers →