EU → North America Device Access

VITROMED GmbH

DE-MF-000005131 · Germany · Jena

VITROMED GmbH is registered in the European database on medical devices as a manufacturer, with 108 devices declared. It is also registered as a device establishment with the U.S. FDA.

What this manufacturer declares

Class IIa76
Class IIb2
Class I6

Among these devices, 107 are declared sterile.

Devices declared under this manufacturer

Showing 12 of 108 declared devices.

Catalogue references include V-CTU-15, V-DEN-140, V-GRD00_100P, V-INJ-S1-30, V-INJ-S3-20, V-SRO-10.

European nomenclature codes declared: U0802030106, U0802030104, U0802030108, U0802030102, U08020599, U0802030103.

United States market access

FDA establishment registerRegistered with FDA
Matched entryVITROMED GmbH (DE) · FDA 3016126174
Devices in EUDAMED108
Country of registrationGermany

Device-level evidence

Devices with a numeric GTIN108
Found in the U.S. device database43
Share39.8 %

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: United States only. VITROMED GmbH is registered in the United States but was not found in the Canadian register.

Notified body certificates

CertificateStatusExpiry
2270294CE01supplemented2029-12-01

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