EU → US Device Access

URSAPHARM Arzneimittel GmbH

DE-MF-000007748 · Germany · Saarbrücken

URSAPHARM Arzneimittel GmbH is registered in the European database on medical devices as a manufacturer, with 44 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb30
Class IIa14

Most frequent device types declared: Lubricating eye drops, Lubricating eye ointment, Self-heating eye mask, Moistening solution for nasal use, Salt solution for nasal use.

Among these devices, 39 are declared sterile.

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 EUDAMED44
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
HZ 1010771-1supplemented2029-12-12

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