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LoFric Sense Nelaton 15cm CH08
EUDAMEDFDA 510(k)Class I (EU MDR)
Ref 4160870510(k) K123751
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
- 4160870 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07333387021331 EUDAMED
- Basic UDI-DI
- 733338724101CV EUDAMED
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Sweden EUDAMEDFrance 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 — FDA_510K, MDR — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
United States Active
FDA_510K
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K123751 | Class I | Active |
| EUDAMED | European Union | CE/MDR | 733338724101CV | Class I | Active |
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Manufacturer
- Manufacturer
- Wellspect HealthCare
- EUDAMED SRN
- SE-MF-000026271
Sources (3)
- EUDAMED 464d9297-4d65-4c1c-818e-eaed9ea0fdf7 85 fields · synced Oct 6, 2026
- EUDAMED 23e91437-0ffe-43a8-82d3-049fe3fc7f8e 61 fields · synced Jul 26, 2026
- FDA 510(k) K123751 1 fields · synced May 18, 2026