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Gloveins Alpha Coiled

by Global Medikit Limited 14 variants

Ref 4512001GModel Extension set (Low & high pressure), coiled extension set with & without needle free connector, Extension line with &without needle free valve, Extension tube with clamp

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 Number8903545GMLEXT020N8 Basic UDI-DI 08903545085735UDI-DIDate7 Aug 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  • Withdrawn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
Extension Set
Model / Reference
Extension set (Low & high pressure), coiled extension set with & without needle free connector, Extension line with &without needle free valve, Extension tube with clamp, 4512001G
Primary DI / UDI-DI
08903545085735
Basic UDI-DI
8903545GMLEXT020N8
EMDN Code
A03020102 High pressure extension lines
Device Class
Class IIa
EU market of registration
Greece

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