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Omnipod Insulin Management System

by Insulet Corporation 16 variants

Ref 18916-6L

Active European Union

CE MDD

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-20385081120194 Basic UDI-DI 20385081120194UDI-DIDate18 Feb 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  • Withdrawn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/MDD Active

Specification

EUDAMED

Model / Reference
18916-6L
Primary DI / UDI-DI
20385081120194
Basic UDI-DI
B-20385081120194
EMDN Code
Z120402160101 Portable insulin microinfusors
Device Class
Class IIb
EU market of registration
Netherlands

Manufacturer details

EUDAMED SRN
US-MF-000007948
Authorised representative
Insulet Netherlands B.V. NL-AR-000002337

Other devices from Insulet Corporation

See all devices from Insulet Corporation →

Properties

  • Sterile
  • Measuring Function

Other properties (9)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No