EU → North America Device Access

Comecer Netherlands B.V.

NL-MF-000026292 · Netherlands · Joure

Comecer Netherlands B.V. is registered in the European database on medical devices as a manufacturer, with 6 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa6

Most frequent device types declared: RDC-VIK-202 with IBC-Lite.

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

Catalogue references include 0202020088, 0202020160, 0202020161, 0202020171, 0202020172, 0202020173.

European nomenclature codes declared: Z11029005.

United States market access

FDA establishment registerRegistered with FDA
Matched entryComecer Netherlands b.v. (NL) · FDA 3009694288
Devices in EUDAMED6
Country of registrationNetherlands

Device-level evidence

Devices with a numeric GTIN6
Found in the U.S. device database2
Share33.3 %

Canadian market access

Health Canada licence listingLicensed in Canada
Matched entryCOMECER NETHERLANDS B.V.

North American profile: Both markets. Comecer Netherlands B.V. is registered in both the United States and Canada.

Notified body certificates

CertificateStatusExpiry
2267926CE01supplemented2028-02-01

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