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Transfuseurs à usage unique

by Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd Tunisia EUDAMED

Ref TSCA22LLCCModel Chambre de compte-goutte Avec ou sans régulateurs, Embout: de forme variable

EMDN A03010102

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number61924931TRANSFUSEURNU Basic UDI-DIDate21 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Transfuseurs à usage unique
Model / Reference
Chambre de compte-goutte Avec ou sans régulateurs, Embout: de forme variable, TSCA22LLCC
Primary DI / UDI-DI
06192493100955
Basic UDI-DI
61924931TRANSFUSEURNU
EMDN Code
A03010102 Infusion controllers with filter (also transfusion controllers)
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
TN-MF-000023623
Authorised representative
Obelis s.a. BE-AR-000000106

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Contains Latex
Other properties (11)
  • Implantable: No
  • Reusable: 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 (1)

  • EUDAMED dbab75b1-65ec-492e-a1aa-1a28eb0b0e8d 61 fields · synced 22 Oct 2026