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Omnipod Insulin Management System
EUDAMEDClass IIb (EU MDR)
Ref PDM-FRT400Model 18900-5D
Identity
- Trade Name
- Omnipod Insulin Management System EUDAMED
- Device Name
- PDM-FRT400 EUDAMED
- Model / Reference
- 18900-5D EUDAMEDPDM-FRT400 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10385081120074 EUDAMED
- Basic UDI-DI
- B-10385081120074 EUDAMED
- EMDN Code
- Z120402160101 PORTABLE INSULIN MICROINFUSORS EUDAMED
Classification
- Device Class
- Class IIb EUDAMED
- Market of Registration
- France 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-10385081120074 | 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 51eddf43-e1b0-4a7e-8efc-95948f505286 61 fields · synced Jun 9, 2026