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Omnipod Insulin Management System

by Insulet Corporation 16 variants

Ref 18916-5T

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD NumberB-20385081120163 Basic UDI-DI 20385081120163UDI-DIDate8 Apr 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  • Withdrawn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

Device Name
Skt-DAT450
Model / Reference
18916-5T
Primary DI / UDI-DI
20385081120163
Basic UDI-DI
B-20385081120163
EMDN Code
Z120402160102 Portable insulin microinfusors with handheld glucose meter
Device Class
Class IIb
EU market of registration
Denmark

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

  • Administering Medicine
  • Measuring Function

Other properties (9)

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