EU → North America Device Access

TeMeCo B.V.

NL-MF-000011503 · Netherlands · Heerhugowaard

TeMeCo B.V. is registered in the European database on medical devices as a manufacturer, with 7 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa7

Among these devices, 7 are declared active, 7 with a measuring function.

Devices declared under this manufacturer

Catalogue references include SL01, SLE-12IEC, SLE-3IEC, SLE-5IEC, SLEM-001, SLOM-001.

European nomenclature codes declared: Z12050403.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED7
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 GTIN7
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. TeMeCo B.V. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
21M00198CRT01issued2027-09-29

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