EU → North America Device Access

MARTIKAN s.r.o.

SK-MF-000005834 · Slovakia · Dolná Mariková

MARTIKAN s.r.o. is registered in the European database on medical devices as a manufacturer, with 585 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIb444
Class IIa141

Most frequent device types declared: MPU, MPŠ; CPS, MS, MTID, P.

Among these devices, 444 are declared implantable, 72 reusable.

Devices declared under this manufacturer

Showing 12 of 585 declared devices.

Catalogue references include BLI-14L, CPS-15-143-R45, MLS 3,6, N 126, N 3HR-1,3, P 12.

European nomenclature codes declared: P01020101, P01020180, L159099, Q010207.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED585
Country of registrationSlovakia

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

Device-level evidence

Devices with a numeric GTIN585
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. MARTIKAN s.r.o. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
2022-MDR/TD-003/Asupplemented2027-07-20
2022-MDR/QS-003/Asupplemented2027-07-20

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