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Vitrex

by Sandstone Medical(Suzhou) Inc. China EUDAMED

Ref 531313 31G×5mm

EMDN A0101010201

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697285729052C Basic UDI-DIDate1 Jun 2023RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 23 Oct 2026

Device Name
Safety Pen Needles
Model / Reference
531313 31G×5mm
Primary DI / UDI-DI
16972857292840
Basic UDI-DI
697285729052C
Unit of Use DI
06972857292843
EMDN Code
A0101010201 Hypodermic pen needles, with safety systems
Device Class
Class IIa
Market of Registration
Denmark

Manufacturer details

EUDAMED SRN
CN-MF-000011105
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Other devices from Sandstone Medical(Suzhou) Inc.

See all devices from Sandstone Medical(Suzhou) Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • 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

Sources (1)

  • EUDAMED 1914a05c-9703-4afe-b188-da736545897d 61 fields · synced 23 Oct 2026