EU → North America Device Access

Noventure S.L.U.

ES-MF-000000797 · Spain · BARCELONA

Noventure S.L.U. is registered in the European database on medical devices as a manufacturer, with 16 devices declared. It was not found in the U.S. FDA device establishment register.

What this manufacturer declares

Class I12
Class IIa3
Class IIb1

Most frequent device types declared: Oleoabrax tube, Tasectan capsules, Tasectan sachets, UTA423, UTIPRO PLUS AF capsules.

Devices declared under this manufacturer

Showing 12 of 16 declared devices.

Catalogue references include 000000, 1291481, 1308499, 1308500, 1308533, 1308534.

European nomenclature codes declared: G99, G0499, G0402, M04040501, G0401.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
Country of registrationSpain

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

Device-level evidence

Devices with a numeric GTIN14
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. Noventure S.L.U. was not found in either the U.S. or the Canadian register.

Notified body certificates

CertificateStatusExpiry
MDR00064-Cissued2029-11-14
MDR 00064-Cissued2029-11-14
MDR 00064-Bissued2029-11-14
MDR 00064-Aissued2029-11-14
CVD0023230226amended2028-12-21
CSQ0016230226amended2028-12-21

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