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Seringues Insuline, à usage unique

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

Ref SI001SE29BModel differents Diamètre et longeur de l'aiguille, volume de la seringue EMDN A02010601

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number61924931INSULINSYRINGES3Z Basic UDI-DIDate16 May 2025RegisteredStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
differents Diamètre et longeur de l'aiguille, volume de la seringue, SI001SE29B
Primary DI / UDI-DI
06192493100566
Basic UDI-DI
61924931INSULINSYRINGES3Z
EMDN Code
A02010601 Insulin syringes with fixed needle, single-use
Device Class
Class IIa
Market of Registration
France

Manufacturer details

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

Other devices from Societe de Fabrication des Articles Pharmaceutiques SO.F.A.P Ltd

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Properties & raw data

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

Sources (1)

  • EUDAMED 111ab7dd-dd3d-450f-984f-9c8321ac5cce 61 fields · synced 24 Oct 2026