embecta Pen Needles

by embecta Medical II LLC 16 variants

Ref 320604Model Pen Needle

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
European Union	CE/MDR	Number0383017LGPNNDLSCPVK Basic UDI-DI 50383017060454UDI-DI	Date3 Sep 2026Registered	StatusActive 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

Active
Expiring
Withdrawn
Listed
Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device Name: Ultra-Fine; Nano; Micro-Fine; Ultra-Fine PRO; Micro-Fine PRO; Viva; Nano 2nd Gen; Base-Fine; embecta;
Model / Reference: Pen Needle, 320604

Primary DI / UDI-DI: 50383017060454
Basic UDI-DI: 0383017LGPNNDLSCPVK
Unit of Use DI: 80383017060486
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

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Properties

Sterile
Administering Medicine

Other properties (11)