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Klinion

by Genray Hangzhou Life Technology Co., Ltd. China EUDAMED

Ref 5296

EMDN A0101010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697510050XPNR3 Basic UDI-DIDate3 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
X-Safety pen needle
Model / Reference
5296
Primary DI / UDI-DI
06975100500337
Basic UDI-DI
697510050XPNR3
Unit of Use DI
86975100500333
EMDN Code
A0101010201 Hypodermic pen needles, with safety systems
Device Class
Class IIa
Market of Registration
Netherlands

Manufacturer details

EUDAMED SRN
CN-MF-000038113
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Genray Hangzhou Life Technology Co., Ltd.

See all devices from Genray Hangzhou Life Technology Co., Ltd. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 214434b2-f944-473c-95c7-f69130644be2 61 fields · synced 22 Oct 2026