Identity
- Trade Name
- SenSura Xpro EUDAMED
- Device Name
- SenSura Xpro click urostomy bag and baseplate (set 2-piece) EUDAMED
- Model / Reference
- 17548 EUDAMED17545 EUDAMED17547 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05708932772808 EUDAMED05708932772716 EUDAMED05708932772778 EUDAMED
- Basic UDI-DI
- 5708932124378361KT EUDAMED
- EMDN Code
- A1002010401,A10020402 EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Spain 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 Xpro 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 | 5708932124378361KT | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (3)
- EUDAMED cdf2efc5-4045-47c1-a3d5-865aff82e3b4 61 fields · synced Jul 21, 2026
- EUDAMED fc76f6e2-a643-432c-8ed5-1d232af4b06f 61 fields · synced May 16, 2026
- EUDAMED a242d9a8-18ac-4ff0-99db-b8ca75022f2d 61 fields · synced May 18, 2026