Identity
- Trade Name
- Navina™ Classic System Regular EUDAMED
- Device Name
- Navina, Bowel Management System EUDAMED
- Model / Reference
- 6900581 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333387025988 EUDAMED
- Basic UDI-DI
- 733338724104D3 EUDAMED
- EMDN Code
- G020199 GASTROINTESTINAL LAVAGE, TUBES AND SETS - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden 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™ Classic System Regular by Wellspect HealthCare — 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 | 733338724104D3 | Class I | Active |
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Manufacturer
- Manufacturer
- Wellspect HealthCare
- EUDAMED SRN
- SE-MF-000026271
Sources (1)
- EUDAMED e5d97d54-1e96-48d0-9981-7fcb3e9dd933 61 fields · synced Jun 9, 2026