Identity
- Trade Name
- LoFric Sense Nelaton 15cm CH08 EUDAMEDLoFric Sense EUDAMED
- Device Name
- Single use hydrophilic urinary catheter for intermittent urinary catheterization EUDAMED
- Model / Reference
- 4160865 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333387021300 EUDAMED
- Basic UDI-DI
- 733338724101CV EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMEDBelgium EUDAMED
Clinical & Handling
Sterile
Yes
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
LoFric Sense Nelaton 15cm CH08 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 | 733338724101CV | Class I | Active |
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Manufacturer
- Manufacturer
- Wellspect HealthCare
- EUDAMED SRN
- SE-MF-000026271
Sources (2)
- EUDAMED 6a9553e2-20a1-4169-9d8d-13644a387319 61 fields · synced Jun 19, 2026
- EUDAMED 37bb1f15-c647-4915-9715-19d18a1fdecc 61 fields · synced Jun 19, 2026