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MEDRAD® Stellant Syringe Kits

by Bayer Medical Care Inc. EUDAMED

Active European Union

Ref SDS-TRF-CV

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0616258TFCN-0050Q5 Basic UDI-DIDate14 May 2026RegisteredStatusActive

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  • Withdrawn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

Model / Reference
SDS-TRF-CV
Primary DI / UDI-DI
00616258024615
Basic UDI-DI
0616258TFCN-0050Q5
EMDN Code
A02010401 Syringes for contrast media injector, single-use
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007050
Authorised representative
Bayer Medical Care B.V. NL-AR-000000240

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Properties

Show properties
  • Sterile
Other properties (12)
  • 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