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UMONIUM38® Equipments 125ml

by Laboratoire Huckert's International Belgium EUDAMED

Ref PF12314 EMDN D0901

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR NumberB-05425037712101 Basic UDI-DIDate19 Apr 2025RegisteredStatusActive
European UnionCE/MDD NumberB-05425037712101 Basic UDI-DIDate19 Apr 2025RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR, CE/MDD Active

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • BE26/00000024 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    7 Jul 2026
    Expires
    28 Jan 2031

Specification

EUDAMED · synced 25 Oct 2026

Device Name
UMONIUM38® Equipments 5L
Model / Reference
PF12314
Primary DI / UDI-DI
05425037712101, 05425037715638
Basic UDI-DI
B-05425037712101, 542503771UCEQ001BY
EMDN Code
D0901, D0902
Device Class
Class IIa
Market of Registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000024078

Other devices from Laboratoire Huckert's International

See all devices from Laboratoire Huckert's International →

Properties & raw data

Show properties, registry sources and raw records
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

Sources (2)

  • EUDAMED ca08b789-f72e-4cf4-a3cd-91328d9bcf50 61 fields · synced 22 Oct 2026
  • EUDAMED 05425037715638|542503771UCEQ001BY 61 fields · synced 25 Oct 2026