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SmartDose

by Allergan Sales, LLC 2 variants

Ref 100012369

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number0840228300V001065CN Basic UDI-DI 00840228303343UDI-DIDate29 Sep 2026RegisteredStatusActive

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  • Withdrawn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
SmartDose On-Body Delivery System (1.2 ml)
Model / Reference
100012369
Primary DI / UDI-DI
00840228303343
Basic UDI-DI
0840228300V001065CN
EMDN Code
A03040199 Infusion kits (with or w/o pump), single-use - other
Device Class
Class IIa
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
US-MF-000001517
Authorised representative
Allergan Pharmaceuticals International Limited IE-AR-000000650

Other devices from Allergan Sales, LLC

See all devices from Allergan Sales, LLC →

Properties

  • 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