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embecta Pen Needles

by embecta Medical II LLC United States EUDAMED

Ref 320120Model Pen Needle

EMDN A0101010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number383017LGPNNDLSCP Basic UDI-DIDate26 Mar 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 22 Oct 2026

Device Name
Ultra-Fine; Nano; Micro-Fine; Ultra-Fine PRO; Micro-Fine PRO; Viva; Nano 2nd Gen; Base-Fine; embecta;
Model / Reference
Pen Needle, 320120
Primary DI / UDI-DI
60383017012061
Basic UDI-DI
383017LGPNNDLSCP, 0383017LGPNNDLSCPVK
Unit of Use DI
80383017012089, 90383017012093
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa

Manufacturer details

EUDAMED SRN
US-MF-000044225
Authorised representative
embecta Penel Limited IE-AR-000040945

Other devices from embecta Medical II LLC

See all devices from embecta Medical II LLC →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile
  • Administering Medicine
Other properties (11)
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No

Sources (2)

  • EUDAMED 4c5f99e2-1dcb-4915-90c8-a74ca295c29e 61 fields · synced 22 Oct 2026
  • EUDAMED 60383017012061|0383017LGPNNDLSCPVK 61 fields · synced 20 Jun 2026