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Glofin

by Global Medikit Limited 3 variants

Ref 2011155GModel A.V. fistula needle set (Safety and without safety)

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8903545GMLAVF006H2 Basic UDI-DI 08903545002350UDI-DIDate28 Jun 2023RegisteredStatusActive

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  • Withdrawn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

Device Name
A.V fistula needle
Model / Reference
A.V. fistula needle set (Safety and without safety), 2011155G
Primary DI / UDI-DI
08903545002350
Basic UDI-DI
8903545GMLAVF006H2
EMDN Code
A010401 Arteriovenous fistula needles
Device Class
Class IIa
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
IN-MF-000013635
Authorised representative
Obelis s.a. BE-AR-000000106

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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