Skip to content

Pen Needles

by Sandstone Medical(Suzhou) Inc. China EUDAMED

Ref F19003 32G×4mm EMDN A0101010202

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6972857290124 Basic UDI-DIDate4 May 2023RegisteredStatusWithdrawn Not intended for the EU market

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Withdrawn

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 25 Oct 2026

Model / Reference
F19003 32G×4mm
Primary DI / UDI-DI
06972857292638
Basic UDI-DI
6972857290124
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa

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 bfcc3cf8-035d-4c00-bd15-bd58e4d0eb3b 61 fields · synced 25 Oct 2026