EU → US Device Access

HiPer Medical AG

DE-MF-000008894 · Germany · Oberkrämer

HiPer Medical AG is registered in the European database on medical devices as a manufacturer, with 91 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I91

Most frequent device types declared: ceramic hip implant.

Among these devices, 91 are declared sterile, 91 implantable.

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 EUDAMED91
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
6608GB448230109issued2027-01-12
12970GB450250320supplemented2028-01-08

Other manufacturers in Germany

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