Identity
- Trade Name
- SenSura Flex EUDAMED
- Device Name
- SenSura Flex ostomy bag 2-piece closed EUDAMED
- Model / Reference
- 13218 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932386142 EUDAMED
- Basic UDI-DI
- 57089322975128L EUDAMED
- Unit of Use DI
- 05701780092883 EUDAMED
- EMDN Code
- A10020202,A10020302 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Netherlands 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 6016e83f-9f62-409f-8220-0b131f037be1 61 fields · synced May 21, 2026