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Gloflon Safety

by Global Medikit Limited 3 variants

Ref 4580262GModel I.V. Catheter with & without Injection valve and with & without wings (with & without safety); I.V. Catheter with an integrated 3 way stop cock (with & without safety); I.V catheter for infants; I.V. catheter for quick flash back (with & 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 Number8903545GMLIVC019KW Basic UDI-DI Date13 Jul 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  • Withdrawn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
I.V. Catheter
Model / Reference
I.V. Catheter with & without Injection valve and with & without wings (with & without safety), I.V. Catheter with an integrated 3 way stop cock (with & without safety), I.V catheter for infants, I.V. catheter for quick flash back (with & without safety), 4580262G
Primary DI / UDI-DI
08903545071936, 08903545079444
Basic UDI-DI
8903545GMLIVC019KW
EMDN Code
C0101010201 Peripheral i.v. catheters, with safety systems, with injection valves
Device Class
Class IIa
EU market of registration
Romania

Manufacturer details

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

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Properties

  • 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