EU → North America Device Access

Medica Europe B.V.

NL-MF-000000118 · Netherlands · Oss

Medica Europe B.V. is registered in the European database on medical devices as a manufacturer, with 1 346 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa1 346

Among these devices, 561 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 1 346 declared devices.

Catalogue references include 08871, 109899AA, 117054AA, 1301298, 1301976, 1302676.

European nomenclature codes declared: T020199, T020102, T030102, T020401, S010302, T01020204.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED1 346
Country of registrationNetherlands

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

Device-level evidence

Devices with a numeric GTIN1 346
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. Medica Europe B.V. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
MDR 734870supplemented2030-11-29

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