Skip to content

Pen Needles

by Sandstone Medical(Suzhou) Inc. 40 variants

Part of a family of 61 devices: see the family page

Ref I23204

Pen Needles (I23204) is a Class IIa device made by Sandstone Medical(Suzhou) Inc., registered in EUDAMED on 4 May 2023 (Basic UDI-DI 6972857290124), active as of 23 Oct 2026.

Active European Union

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number6972857290124 Basic UDI-DI 16972857293069UDI-DIDate4 May 2023RegisteredStatusActive EUDAMED: not on the EU market

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / reference
I23204
Primary DI / UDI-DI
16972857293069
Basic UDI-DI
6972857290124
Unit of use DI
06972857293062
EMDN code
A0101010202 Hypodermic pen needles, w/o safety systems
Device class
Class IIa
EU registration type
Standard device

Manufacturer details

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

Similar devices in this category

Other devices filed under HYPODERMIC PEN NEEDLES, W/O SAFETY SYSTEMS.

Other devices from Sandstone Medical(Suzhou) Inc.

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

Properties

  • Supplied sterile
Other properties (13, all answered No)