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Utipro Plus AF

by Noventure S.L.U.

Ref 000000Model Utipro Plus AF tablets

Active European Union

CE MDR

Valid until

14 Nov 2029

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

2 certificates

Certifier KIWA CERMET ITALIA S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 00064-A Date27 Mar 2025IssuedStatusActive EUDAMED: not on the EU market expires 14 Nov 2029

Certificates

2 certificates · EUDAMED

EUDAMED certificates (2)
  • MDR 00064-A Active

    Quality management system EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    27 Mar 2025
    Expires
    14 Nov 2029
  • MDR 00064-B Active

    Technical documentation EU MDR

    Certifier
    KIWA CERMET ITALIA S.P.A. 0476
    Issued
    27 Mar 2025
    Expires
    14 Nov 2029

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Utipro Plus AF tablets
Model / Reference
Utipro Plus AF tablets, 000000
Primary DI / UDI-DI
08436593831349
Basic UDI-DI
843659383UTA433QH
EMDN Code
G0499 Orally administered gastrointestinal devices - other
Device Class
Class III

Manufacturer details

EUDAMED SRN
ES-MF-000000797

Other devices from Noventure S.L.U.

See all devices from Noventure S.L.U. →

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No