Identity
- Trade Name
- Navina Smart Control Unit EUDAMED
- Device Name
- Navina, Bowel Management System EUDAMED
- Model / Reference
- 6901445 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333387028743 EUDAMED
- Basic UDI-DI
- 733338724105D5 EUDAMED
- EMDN Code
- G020301 RECTAL TUBES EUDAMED
Classification
- Device Class
- Class IIa EUDAMED
- Market of Registration
- Finland 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
Navina Smart Control Unit by Wellspect HealthCare — Class IIa — 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 | 733338724105D5 | Class IIa | Active |
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Manufacturer
- Manufacturer
- Wellspect HealthCare
- EUDAMED SRN
- SE-MF-000026271
Sources (1)
- EUDAMED e14f2b74-dfcc-47f9-a5c5-eee8517c63ce 61 fields · synced Jul 8, 2026