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embecta Pen Needles

by embecta Medical II LLC United States EUDAMED

Ref 321137Model Pen Needle

EMDN A0101010202

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0383017BYNDPNNDLEONC Basic UDI-DIDate14 Aug 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Not covered

European Union — CE/MDR Active

Certificates: none listed in EUDAMED

Specification

EUDAMED · synced 24 Oct 2026

Device Name
embecta Pen Needle
Model / Reference
Pen Needle, 321137
Primary DI / UDI-DI
00383017113735
Basic UDI-DI
0383017BYNDPNNDLEONC
Unit of Use DI
80383017113786
EMDN Code
A0101010202 Hypodermic pen needles, w/o safety systems
Device Class
Class IIa
Market of Registration
Netherlands

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 (1)

  • EUDAMED 00383017113735|0383017BYNDPNNDLEONC 61 fields · synced 24 Oct 2026