EU → North America Device Access

Medicop - specialna oprema d.o.o.

SI-MF-000002144 · Slovenia · Murska Sobota

Medicop - specialna oprema d.o.o. is registered in the European database on medical devices as a manufacturer, with 28 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa28

Most frequent device types declared: AGSS, Bead Head Unit, CCB, EQSens Flow, FQ.

Among these devices, 3 are declared implantable, 27 active, 6 with a measuring function.

Devices declared under this manufacturer

Showing 12 of 28 declared devices.

Catalogue references include 3-en-Instruction_manual_AGSS_plant v1.4, IM.AFNORTU.Maj 2020 II, IM.DINSTU.Maj 2020 II, IZ08389_EQSens_FLOW_COLUMN_EN, Instruction_manual_BHU_Medicompact v2.4 EN, Instruction_manual_SmartLet v2.01 EN.

European nomenclature codes declared: Z120309, A0601010201, A030104, A03020101.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED28
Country of registrationSlovenia

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

Device-level evidence

Devices with a numeric GTIN28
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. Medicop - specialna oprema d.o.o. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
G10 038393 0019issued2029-04-21

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