EU → US 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: SVMB, MPŠ; CPS, MV; CMV, MTID, MTI.

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

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED585
Country of registrationSlovakia
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

Notified body certificates

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

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