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Glopsine

by Global Medikit Limited

Ref 643124GPModel Spinal needle (Quincke Bevel without Introducer Needle);Spinal needle (Pencil point without Introducer Needle);Spinal needle Pencil point with Introducer Needle

Active European Union

CE MDR

Valid until

6 Feb 2028

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier TÜV SÜD Product Service GmbH

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number8903545GMLSPN002PS Basic UDI-DI 08903545081270UDI-DIDate19 Jun 2023RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Spinal Needle
Model / Reference
Spinal needle (Quincke Bevel without Introducer Needle), Spinal needle (Pencil point without Introducer Needle), Spinal needle Pencil point with Introducer Needle, 643124GP
Primary DI / UDI-DI
08903545081270
Basic UDI-DI
8903545GMLSPN002PS
EMDN Code
A01030101 Spinal anaesthesia needles and kits
Device Class
Class III
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
  • 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