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Closed System Drug Transfer Device (CSTD)

by Poly Medicure Limited India EUDAMED

Ref 50386Model CSTD Syringe Units

EMDN A0704

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890209550382FM Basic UDI-DIDate14 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Model / Reference
CSTD Syringe Units, 50386
Primary DI / UDI-DI
08902095503867
Basic UDI-DI
890209550382FM
EMDN Code
A0704 Systems for reconstitution and administration of pharmaceuticals
Device Class
Class I
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000043011
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Poly Medicure Limited

See all devices from Poly Medicure Limited →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (1)

  • EUDAMED 08902095503867|890209550382FM 61 fields · synced 24 Oct 2026