EU → North America Device Access

Zepf Medical Instruments GmbH

DE-MF-000005528 · Germany · Seitingen-Oberflacht

Zepf Medical Instruments GmbH is registered in the European database on medical devices as a manufacturer, with 14 808 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa14 699
Class IIb109

Most frequent device types declared: Kanüle, Absaugung, Klemme, Arterie, Klemme, sonstige, Kürette, Meißel, Nase.

Among these devices, 26 are declared sterile, 14 607 reusable, 109 active, 4 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 14 808 declared devices.

Catalogue references include 11-1076-15, 12-3300-14, 13-2007-20, 18-7195-00, 32-5006-06, 46-4700-07.

European nomenclature codes declared: L031308, S010499, L050901, L159001, L03140101, L03140199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryZEPF MEDICAL INSTRUMENTS GMBH (DE) · FDA 3003244954
Devices in EUDAMED14 808
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN14 808
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: United States only. Zepf Medical Instruments GmbH is registered in the United States but was not found in the Canadian register.

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