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UDI Compass
Unknown / Not in EUDAMED

Snapshot 2026-10-19 · Link to EUDAMED

Omnipod 5 Automated Insulin Delivery System

UDI-DI 10385083001012Basic UDI-DI 038508AIDSH

Class III · MDR · Insulet Corporation

Identification
Model
—
Issuing agency
GS1
Device status
active
Sterile
Yes
Implantable
No
Measuring function
Yes
Reusable surgical
No
Certificates

MDR 773619

EU technical documentation assessment · unknown

Notified body: BSI Group The Netherlands B.V. (2797)

Valid from 2026-06-09 · Expiry 2027-09-15

Scope not stated in certificate data.

Certificate’s own scope text — not a compliance opinion from UDI Compass.

Manufacturer

Insulet Corporation

SRN US-MF-000007948

US · Acton - Massachusetts

manufacturer

Authorised representative: Insulet Netherlands B.V. (NL-AR-000002337)

Related UDI-DIs

Showing 12 of 23 other UDI-DIs.

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Canonical device page: /device/omnipod-5-automated-insulin-delivery-system-1012 · UDI page: /udi/10385083001012

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