Identity
- Trade Name
- Omnipod Insulin Management System EUDAMED
- Device Name
- SKT-NOT450 EUDAMED
- Model / Reference
- 18916-5M EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20385081120132 EUDAMED
- Basic UDI-DI
- B-20385081120132 EUDAMED
- EMDN Code
- Z120402160102 PORTABLE INSULIN MICROINFUSORS WITH HANDHELD GLUCOSE METER EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- Norway EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Omnipod Insulin Management System by Insulet Corporation — Class IIb — MDD — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-20385081120132 | Class IIb | Active |
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Manufacturer
- Manufacturer
- Insulet Corporation
- EUDAMED SRN
- US-MF-000007948
- Authorised Representative
- Insulet Netherlands B.V. NL-AR-000002337
Sources (1)
- EUDAMED 0d495414-5c0c-476c-ba05-90530cccf1fc 61 fields · synced Jun 9, 2026