EU → US 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: Tasectan sachets, Tasectan capsules, XILAPLUS AF capsules, UTIPRO PLUS AF capsules, Oleoabrax tube.

No authorised representative is recorded for these devices. For a manufacturer established outside the Union that would be unusual; for one established inside it, it is normal.

United States market access

FDA establishment registerNot found in the FDA register
Devices in EUDAMED16
Country of registrationSpain
⚠️ Absence here is not proof of absence from the market. A manufacturer may reach the United States through a distributor registered under its own name, or under a corporate name we could not match. We publish what we measured, not what we inferred.

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

Other manufacturers in Spain

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