Identity
- Trade Name
- SenSura Convex EUDAMED
- Device Name
- SenSura Convex ostomy bag 1-piece open EUDAMED
- Model / Reference
- 11277 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05701780391085 EUDAMED
- Basic UDI-DI
- 5708932122664335JQ EUDAMED
- Unit of Use DI
- 05701780391108 EUDAMED
- EMDN Code
- A1001010202,A1001020202 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Portugal 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 Convex 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 | 5708932122664335JQ | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 262c9cf5-af92-4acb-b371-eef11fd5ad5c 61 fields · synced May 23, 2026