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Navina™ Classic Control Unit
EUDAMEDClass I (EU MDR)
Ref 6901330Ref 6901345Ref 6901370Ref 6901380Ref 6901365Ref 6901315
Identity
- Trade Name
- Navina™ Classic Control Unit EUDAMED
- Device Name
- Navina, Bowel Management System EUDAMED
- Model / Reference
- 6901330 EUDAMED6901345 EUDAMED6901370 EUDAMED6901380 EUDAMED6901365 EUDAMED6901315 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333387028309 EUDAMED07333387028361 EUDAMED07333387028453 EUDAMED07333387028484 EUDAMED07333387028422 EUDAMED07333387028279 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 Control Unit 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 (6)
- EUDAMED 87b2d765-f481-4b06-ad0f-38c56bc4ea84 61 fields · synced Oct 6, 2026
- EUDAMED f9dba652-cf45-4ce6-9516-93b3e4e799aa 61 fields · synced May 17, 2026
- EUDAMED 6a91891e-42a7-4272-8de2-7f9628f09fab 61 fields · synced May 17, 2026
- EUDAMED b07a29f8-2dc7-4d65-a7d6-316ab2bdfb04 61 fields · synced May 18, 2026
- EUDAMED bd37bdc3-8960-458e-8b1d-765f2a35d163 61 fields · synced May 18, 2026
- EUDAMED f5f293b6-6d0d-4af9-bdbf-2b4e481f9aeb 61 fields · synced May 18, 2026