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Navina™ Classic System Small Refill
FDA UDIEUDAMEDClass I (US FDA UDI)
by Wellspect AB
Identity
- Trade Name
- Navina™ Classic System Small Refill FDA UDI
- Generic Name
- Manual rectal irrigation system FDA UDI
- Device Name
- Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal catheters small, Non Sterile Device. Rx Only. FDA UDI
- Model / Reference
- 69008 FDA UDI
- Description
- Navina Classic Transanal Irrigation. 1 Navina Classic control unit, 1 Water container, 1 Tube set, 2 Rectal catheters small, Non Sterile Device. Rx Only. FDA UDI
Identifiers
- Catalog Number
- 6900840 FDA UDI
- Primary DI / UDI-DI
- 07333387026978 FDA UDI
- FDA Product Code
- FCE FDA UDIKNT FDA UDI
- GMDN Term
- Manual rectal irrigation system FDA UDI
Classification
- Device Class
- Class I FDA UDI
- Regulation Number
- 876.5210 FDA UDI876.5980 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Manual rectal irrigation system
Navina™ Classic System Small Refill by Wellspect AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Manual rectal irrigation system.
- Peristeen — Coloplast A/S · Class II
- Centurion — Centurion Medical Products · Class II
- Peristeen — Coloplast A/S · Class II
- Navina™ Classic System Regular — Wellspect AB · Class II
- Navina Mini Extension Set — Wellspect AB · Class I
- Navina™ Mini Start Set — Wellspect AB · Class I
- Navina™ Classic System Refill — Wellspect AB · Class II
- Navina™ Classic System Regular Refill — Wellspect AB · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class I | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class I | Pending data |
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Manufacturer
- Manufacturer
- Wellspect AB
Sources (2)
- FDA UDI 8870bc27-acd3-4e7f-8354-867ff298cf30 36 fields · synced Jun 19, 2026
- EUDAMED 1 fields · synced Jun 2, 2026