EU → US Device Access

TauroPharm GmbH

DE-MF-000008314 · Germany · Waldbüttelbrunn

TauroPharm GmbH is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I11
Class IIb4
Class IIa1

Most frequent device types declared: TP-01, TP-09, TP-05, TP-01-3, TP-50-10.

Among these devices, 16 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 EUDAMED16
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
G70 051963 0029issued2028-04-20
G70 051963 0027supplemented2027-08-15
G12 051963 0028issued2027-07-19

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