Identity
- Trade Name
- SenSura Flex EUDAMED
- Device Name
- SenSura Flex Xpro ostomy baseplate convex EUDAMED
- Model / Reference
- 11308 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932404242 EUDAMED
- Basic UDI-DI
- 57089322976048S EUDAMED
- Unit of Use DI
- 05701780066891 EUDAMED
- EMDN Code
- A1002010402 UNIVERSAL PLATES FOR ABDOMINAL STOMA (COLO-, ILEO-, UROSTOMY) WITH INTROFLEX STOMA EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Finland EUDAMED
Clinical & Handling
Sterile
No
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
SenSura Flex by Coloplast A/S — 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 | 57089322976048S | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 0cebe926-bcc0-4f75-9e0c-c4cf46d2094e 61 fields · synced May 21, 2026