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GlucoRx CarePoint

by Genray Hangzhou Life Technology Co., Ltd. EUDAMED

Active European Union

Ref 1013204, 1013105, 1013106, 1013104, 1013108

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697510050IPNNQ Basic UDI-DIDate2 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED

Device Name
Insulin Pen Needles
Model / Reference
1013204, 1013105, 1013106, 1013104, 1013108
Primary DI / UDI-DI
06975100500719, 06975100500689, 06975100500696, 06975100500672, 06975100500818, 06975100500801, 06975100500702, 06975100500832
Basic UDI-DI
697510050IPNNQ
Unit of Use DI
86975100500715, 86975100500685, 86975100500692, 86975100500678, 86975100500814, 86975100500807, 86975100500708, 86975100500838
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa
Market of Registration
Sweden

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

Show 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