EU → North America Device Access

MedFact Engineering GmbH

DE-MF-000010098 · Germany · Lörrach

MedFact Engineering GmbH is registered in the European database on medical devices as a manufacturer, with 64 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa42
Class I22

Most frequent device types declared: MF0002, MF0009, MF0015, MF0016, MF0020.

Among these devices, 43 are declared sterile, 25 active, 6 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 64 declared devices.

Catalogue references include 103-001, 103-003, 104-001, 104-006, 104-008, 142-002.

European nomenclature codes declared: C0280, C020301, V80, Z12080280, C020199.

United States market access

FDA establishment registerRegistered with FDA
Matched entryMedFact Engineering GmbH (DE) · FDA 3008497357
Devices in EUDAMED64
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN61
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. MedFact Engineering GmbH is registered in the United States but was not found in the Canadian register.

Other manufacturers in Germany

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