EU → US Device Access

Med SSE System GmbH

DE-MF-000008104 · Germany · Nürnberg

Med SSE System GmbH is registered in the European database on medical devices as a manufacturer, with 78 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa78

Most frequent device types declared: A-Tam Analtampon, Contam Vaginaltampon, Med SSE Zubehörartikel für Inkontinenztampons, A-TAM Proktologietampon.

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 EUDAMED78
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
DZ 1620448-1amended2030-09-15

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