Identity
- Trade Name
- PodPals Adhesive Overlay EUDAMEDOmnipod PodPals FDA UDI
- Generic Name
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
- Device Name
- PodPals Adhesive Overlay EUDAMEDOmnipod Adhesive Overlay (PodPals) non-sterile FDA UDI
- Model / Reference
- POD-X9-990NS EUDAMEDFDA UDI
- Description
- Omnipod Adhesive Overlay (PodPals) non-sterile FDA UDI
Identifiers
- Primary DI / UDI-DI
- 10385081120333 EUDAMEDFDA UDI
- Basic UDI-DI
- 038508ADHESIVEY3 EUDAMED
- FDA Product Code
- KGX FDA UDI
- EMDN Code
- M04010199 ADHESIVE DRESSINGS, WITH ABSORBENT PAD - OTHER EUDAMED
- GMDN Term
- Dressing-fixation skin adhesive tape, non-silicone FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 880.5240 FDA UDI
- Market of Registration
- Netherlands EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
PodPals Adhesive Overlay by Insulet Corporation — Class I — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 038508ADHESIVEY3 | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Insulet Corporation
- EUDAMED SRN
- US-MF-000007948
- Authorised Representative
- Insulet Netherlands B.V. NL-AR-000002337
Sources (2)
- EUDAMED d27931d9-b459-491f-b82c-f44adc988ce0 61 fields · synced Jun 18, 2026
- FDA UDI 64b4c3e1-5cf1-40b5-af15-1a644e73cdd0 33 fields · synced May 30, 2026