Identity
- Trade Name
- Assura EUDAMEDFDA UDI
- Generic Name
- Intestinal ostomy base plate, convex FDA UDI
- Device Name
- Assura/Alterna (Original) ostomy baseplate convex EUDAMED
- Model / Reference
- 14297 EUDAMEDFDA UDI
Identifiers
- Catalog Number
- 14297 FDA UDI
- Primary DI / UDI-DI
- 05708932189477 EUDAMED00762123047736 FDA UDI
- Basic UDI-DI
- 57089322976108M EUDAMED
- Unit of Use DI
- 05701780110198 EUDAMED
- FDA Product Code
- EXB FDA UDI
- EMDN Code
- A1002010402 UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH INTROFLEX STOMA EUDAMED
- GMDN Term
- Intestinal ostomy base plate, convex FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5900 FDA UDI
- Market of Registration
- Denmark 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
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
MR Safe FDA UDI
Dimensions & Sizes
- Size
- Lumen/Inner Diameter — 60 Millimeter FDA UDI
Assura by Coloplast A/S — 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 | 57089322976108M | Class I | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (2)
- EUDAMED 1e8dbc9c-9bb2-490f-9b69-d51f16bed6f8 61 fields · synced May 31, 2026
- FDA UDI 387a6ead-b610-4cec-846d-a462f36721ba 35 fields · synced May 30, 2026