EU → North America Device Access

MEDIN, a.s.

CZ-MF-000012371 · Czechia · Nové Město na Moravě

MEDIN, a.s. is registered in the European database on medical devices as a manufacturer, with 2 342 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb2 221
Class IIa121

Most frequent device types declared: Nail, Plate, Screw.

Among these devices, 776 are declared sterile, 2 221 implantable.

Devices declared under this manufacturer

Showing 12 of 2 342 declared devices.

Catalogue references include 397129700093, 397129712334S, 397129781140, 397129781650, 397129788363, 397129795101S.

European nomenclature codes declared: P09120201, P09120601, P09120602, P09120502, P09120501, P09120603.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED2 342
Country of registrationCzechia

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

Device-level evidence

Devices with a numeric GTIN2 342
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. MEDIN, a.s. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2025-MDR/QS-084issued2028-08-31
2024-MDR/TD-058/Asupplemented2029-10-25
2024-MDR/QS-058/Asupplemented2029-10-25
2023-MDR/TD-028/Aissued2028-08-31
2023-MDR/QS-028/Aissued2028-08-31
2023-MDR/QS-028issued2028-08-31

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