EU → North America Device Access

Hans Hepp GmbH & Co. KG

DE-MF-000006024 · Germany · Hamburg

Hans Hepp GmbH & Co. KG is registered in the European database on medical devices as a manufacturer, with 167 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa167

Among these devices, 58 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 167 declared devices.

Catalogue references include 60000, 91493, 92015, 92043, 92075, 92173.

European nomenclature codes declared: M040204, M04010102, M04010101, M04010101,M04010102, M0303010101, M050101.

United States market access

FDA establishment registerRegistered with FDA
Matched entryHANS HEPP GMBH & CO. KG (DE) · FDA 3003364331
Devices in EUDAMED167
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN167
Found in the U.S. device database28
Share16.8 %

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: United States only. Hans Hepp GmbH & Co. KG is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
0462GB449230328amended2027-10-19

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