EU → North America Device Access

Vimex Sp. z o.o.

PL-MF-000008668 · Poland · Gliwice

Vimex Sp. z o.o. is registered in the European database on medical devices as a manufacturer, with 54 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class IIa54

Among these devices, 41 are declared sterile, 2 active.

Catalogue references include 1004.3-7SUTS, 15-1721-200D, 238-45-046, H94-001-050, HL9410-10, N.6910.20 II.

European nomenclature codes declared: A030499, A99, Z12020402.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED54
Country of registrationPoland

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

Device-level evidence

Devices with a numeric GTIN54
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. Vimex Sp. z o.o. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
HZ 1023639-1supplemented2029-10-24

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