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Fresco Infusion Set

by Romsons Group Private Limited EUDAMED

Active European Union

Ref A21-13

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8907265C014YS Basic UDI-DIDate28 Jan 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  • Withdrawn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

Device Name
Infusion Set
Model / Reference
A21-13
Primary DI / UDI-DI
08907265013047
Basic UDI-DI
8907265C014YS
EMDN Code
A03010103 Infusion controllers with flow regulator
Device Class
Class IIa
Market of Registration
Austria

Manufacturer details

EUDAMED SRN
IN-MF-000036506
Authorised representative
Obelis s.a. BE-AR-000000106

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Properties

  • 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