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Pen Needle

by Ningbo Caremed Medical Products Co., Ltd. 10 variants

Ref PN3140Model PN2912,PN3050,PN3051,PN3060,PN3061,PN3080,PN3081, PN3010,PN3011,PN3140,PN3150,PN3160,PN3180,PN3240, PN3250,PN3260,PN3340

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number697454079004LX Basic UDI-DI Date13 Aug 2024RegisteredStatusActive EUDAMED: not on the EU market

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  • Withdrawn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
Sterile insulin pen needles for single use
Model / Reference
PN2912, PN3050, PN3051, PN3060, PN3061, PN3080, PN3081, PN3010, PN3011, PN3140, PN3150, PN3160, PN3180, PN3240, PN3250, PN3260, PN3340
Primary DI / UDI-DI
06974540793200, 06974540793521
Basic UDI-DI
697454079004LX
Unit of Use DI
86974540793206, 86974540793527
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
CN-MF-000012684
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Other devices from Ningbo Caremed Medical Products Co., Ltd.

See all devices from Ningbo Caremed Medical Products Co., Ltd. →

Properties

Other properties (13)

  • Sterile: No
  • 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