EU → US 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: Pessare mit Vakuumeffekt, Ringförmige Pessare, Handgefertigte Pessare, Dr. Arabin Hybrid Pessare, Cerclage Pessar perforiert.

Among these devices, 143 are declared reusable.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED155
Country of registrationGermany
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

CertificateStatusExpiry
1340GB448241217issued2028-07-02

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