Identity
- Trade Name
- Navina Mini Start Set EUDAMED
- Device Name
- Navina, Bowel Management System EUDAMED
- Model / Reference
- 6931030 EUDAMED6931000 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333387047553 EUDAMED07333387047539 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 Mini Start Set 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 (2)
- EUDAMED 3a99c230-99a1-4f97-967a-4339d8637f08 61 fields · synced Jul 28, 2026
- EUDAMED 78eb8001-669b-42dc-a9a0-65f87c87ebdc 61 fields · synced May 19, 2026