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Direxol

by Noventure S.L.U.

Ref 1313112Model XILAPLUS AF capsules

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberMDR 00064-A Date27 Mar 2025IssuedStatusActive 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  • Withdrawn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
XILAPLUS AF capsules
Model / Reference
XILAPLUS AF capsules, 1313112
Primary DI / UDI-DI
08436593831271
Basic UDI-DI
843659383XIA623N6
Direct Marketing DI
08436593831271
EMDN Code
G0401 Orally administered devices for the therapy of gastro-intestinal disorders
Device Class
Class III
EU market of registration
Germany

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