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Contour comfort

by Sandstone Medical(Suzhou) Inc. 5 variants

Ref 04-3105, 04-3106, 04-3204, 04-3108Model Plus Pro

Active European Union

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697285729042A Basic UDI-DI Date17 Feb 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Pen Needles
Model / Reference
Plus Pro, 04-3105, 04-3106, 04-3204, 04-3108
Primary DI / UDI-DI
06972857295714, 06972857295707, 06972857295769, 16972857296244, 06972857295820, 06972857295721, 06972857295844, 16972857296183, 06972857295592, 06972857295608, 06972857295752, 06972857295837, 06972857297589, 06972857297572, 06972857295738, 06972857297534, 06972857296131
Basic UDI-DI
697285729042A
Unit of Use DI
16972857295711, 16972857295704, 16972857295766, 06972857296247, 16972857295827, 16972857295728, 16972857295841, 06972857296186, 16972857295599, 16972857295605, 16972857295759, 16972857295834, 16972857297586, 16972857297579, 16972857295735, 16972857297531, 16972857296138
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa
EU market of registration
Poland
Italy
Portugal
Austria
Spain
France

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

  • 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