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Omnipod 5 Automated Insulin Delivery System

by Insulet Corporation

Ref PT-001443 and PT-002517

Expiring European Union. Also listed in GUDID (US).

CE MDR

Valid until

15 Sep 2027

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier BSI Group The Netherlands B.V.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED NumberMDR 773619 Date9 Jun 2026IssuedStatusExpiring expires 15 Sep 2027
United StatesGUDID listing GUDID Number10385083000411 UDI-DI Date4 Dec 2025ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaNorwaySwedenFinlandDenmarkNetherlandsGermanyFranceBelgiumItaly
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Expiring
  • United States GUDID listing Listed

EU market availability

Made available in 9 countries, as listed in EUDAMED:

Declared by the manufacturer in EUDAMED for this device version; may not cover every market.

  • Belgium since 6 Mar 2024
  • Denmark since 6 Mar 2024
  • Finland since 6 Mar 2024
  • France since 6 Mar 2024
  • Germany since 6 Mar 2024
  • Italy since 6 Mar 2024
  • Netherlands since 6 Mar 2024
  • Norway since 6 Mar 2024
  • Sweden since 6 Mar 2024

Last checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Omnipod 5 Automated Insulin Delivery System EUDAMED
Omnipod 5 Pod GUDID
Generic Name
Ambulatory insulin infusion pump/interstitial glucose monitoring system
Model / Reference
PT-001443 and PT-002517 EUDAMED
POD-OMNI-I1-6220 GUDID
Primary DI / UDI-DI
10385083000411
Basic UDI-DI
038508AIDSH
FDA Product Code
QFG, QJI
EMDN Code
Z120402160103 Portable insulin microinfusors connectable to continuous glucose monitoring systems
GMDN Term
Ambulatory insulin infusion pump/interstitial glucose monitoring system
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
880.5730, 862.1356
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
PT-001443 and PT-002517
GUDID
POD-OMNI-I1-6220
Device ClassEUDAMED
Class III
GUDID
Class II

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
  • Single Use
  • Administering Medicine
  • Measuring Function
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (16)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No