Identity
- Trade Name
- PodPals Adhesive Overlay EUDAMED
- Device Name
- PodPals Adhesive Overlay EUDAMED
- Model / Reference
- POD-X9-999 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 20385081120231 EUDAMED
- Basic UDI-DI
- 038508ADHESIVEY3 EUDAMED
- Direct Marketing DI
- 20385081120231 EUDAMED
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands EUDAMED
Clinical & Handling
Sterile
Yes
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
PodPals Adhesive Overlay by Insulet Corporation — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038508ADHESIVEY3 | Class I | 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 53cc3a9a-1b2b-4102-8fad-98060798c9b7 61 fields · synced Jun 18, 2026