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embecta Pen Needles

by embecta Medical II LLC 30 variants

Ref 321158Model Pen Needle

embecta Pen Needles (321158) is a Class IIa device made by embecta Medical II LLC, registered in EUDAMED on 14 Aug 2026 (Basic UDI-DI 0383017BYNDPNNDLEONC), active as of 7 Nov 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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0383017BYNDPNNDLEONC Basic UDI-DI 00383017115838UDI-DIDate14 Aug 2026RegisteredStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device name
embecta Pen Needle
Model / reference
Pen Needle, 321158
Primary DI / UDI-DI
00383017115838
Basic UDI-DI
0383017BYNDPNNDLEONC
Unit of use DI
80383017115889
EMDN code
A0101010202 Hypodermic pen needles, w/o safety systems
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Netherlands

Manufacturer details

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

Similar devices in this category

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

Other devices from embecta Medical II LLC

See all devices from embecta Medical II LLC →

Properties

  • Supplied sterile
  • Administering medicine
Other properties (12, all answered No)