Identity
- Trade Name
- SenSura EUDAMED
- Device Name
- SenSura click ostomy bag open and baseplate (set 2-piece) EUDAMED
- Model / Reference
- 17538 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 05701780319638 EUDAMED
- Basic UDI-DI
- 5708932124378543L3 EUDAMED
- EMDN Code
- A1002010401,A10020202,A10020302 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 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 | 5708932124378543L3 | Class I | Active |
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Manufacturer
- Manufacturer
- Coloplast A/S
- EUDAMED SRN
- DK-MF-000025526
Sources (1)
- EUDAMED 26523457-5cae-4b5a-8927-a31913672f32 61 fields · synced May 21, 2026