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35-000978-00

by Contract Sterilization Services Pte Ltd Singapore EUDAMED

Ref Custom Pack For Neonate & Infant EMDN C03010101

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-08887851019885 Basic UDI-DIDate25 May 2026RegisteredStatusWithdrawn No longer placed on the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Tubing Set For Extracorporeal Support / Perfusion Tubing Set / Custom Tubing Pack
Model / Reference
Custom Pack For Neonate & Infant
Primary DI / UDI-DI
08887851019885
Basic UDI-DI
B-08887851019885
EMDN Code
C03010101 Extracorporeal circulation circuits
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
SG-MF-000029846
Authorised representative
WMDE B.V. NL-AR-000002062

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
Other properties (10)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED d5891472-14b4-406f-9b20-825638c39144 61 fields · synced 23 Oct 2026