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Burette Infusion sets

by Poly Medicure Limited 49 variants

Ref 14535Model Burette Infusion sets

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number890209514501EM Basic UDI-DI 08902095145357UDI-DIDate13 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
Burette Infusion sets, 14535
Primary DI / UDI-DI
08902095145357
Basic UDI-DI
890209514501EM
EMDN Code
A03010104 Infusion micro-controllers
Device Class
Class IIa
Market of Registration
Italy

Manufacturer details

EUDAMED SRN
IN-MF-000043009
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Poly Medicure Limited

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Properties

  • Sterile
  • Contains Latex
  • Administering Medicine

Other properties (10)

  • Implantable: No
  • Reusable: 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