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Omnipod 5 Automated Insulin Delivery System

by Insulet Corporation 21 variants

Ref PT-000974

Expiring European Union

CE MDR

Valid until

15 Sep 2027

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

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 NumberMDR 773619 Date9 Jun 2026IssuedStatusExpiring expires 15 Sep 2027

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • MDR 773619 Expiring Supplemented Expires in 318 days

    Technical documentation EU MDR

    Certifier
    BSI Group The Netherlands B.V. 2797
    Issued
    9 Jun 2026
    Expires
    15 Sep 2027
    Reason
    Change approved

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Expiring

Specification

EUDAMED

Model / Reference
PT-000974
Primary DI / UDI-DI
10385083000190
Basic UDI-DI
038508AIDSH
EMDN Code
Z120402160103 Portable insulin microinfusors connectable to continuous glucose monitoring systems
Device Class
Class III
EU market of registration
Germany

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 (11)

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