Identity
- Trade Name
- SenSura Flex EUDAMED
- Device Name
- SenSura Flex ostomy bag 2-piece closed EUDAMED
- Model / Reference
- 13212 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932355094 EUDAMED
- Basic UDI-DI
- 57089322975128L EUDAMED
- Unit of Use DI
- 05701780092555 EUDAMED
- EMDN Code
- A10020202,A10020302 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Ireland 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 | 57089322975128L | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 4a31a811-b055-45d9-b3b6-851c3bc9198a 61 fields · synced May 21, 2026