EU → North America 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.

Devices declared under this manufacturer

Showing 12 of 91 declared devices.

Catalogue references include 110130, 110320, 120240, 120390, 120420, 120840.

European nomenclature codes declared: P0908030402, P090804050201, P0908040504.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED91
Country of registrationGermany

⚠️ Not found is not the same as not sold — how this comparison can be wrong.

Device-level evidence

Devices with a numeric GTIN91
Found in the U.S. device database0
Share0.0 %

Canadian market access

Health Canada licence listingNot found in the Canadian register

⚠️ Canada lists no Class I devices at all — what that excludes.

North American profile: Neither register. HiPer Medical AG was not found in either the U.S. or the Canadian register.

Notified body certificates

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

Other manufacturers in Germany

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