Dila-Cath Nelaton 40cm CH16
FDA UDIEUDAMEDClass I (US FDA UDI)
by Wellspect AB
Identity
- Trade Name
- LoFric Dila-Cath EUDAMEDDila-Cath Nelaton 40cm CH16 FDA UDI
- Generic Name
- Urethral dilatation catheter, non-medicated FDA UDI
- Device Name
- Single use hydrophilic urinary catheter for intermittent dilatation of urethra EUDAMEDUrinary catheter for intermittent dilatation FDA UDI
- Model / Reference
- 40616 EUDAMEDFDA UDI
- Description
- Urinary catheter for intermittent dilatation FDA UDI
Identifiers
- Catalog Number
- 4061600 FDA UDI
- Primary DI / UDI-DI
- 07333387040936 EUDAMEDFDA UDI
- Basic UDI-DI
- 733338724108DB EUDAMED
- FDA Product Code
- FBX FDA UDI
- EMDN Code
- U01010501 NELATON CATHETERS, SELF-LUBRICATING EUDAMED
- GMDN Term
- Urethral dilatation catheter, non-medicated FDA UDI
Classification
- Device Class
- Class I EUDAMEDFDA UDI
- Regulation Number
- 876.5520 FDA UDI
- Market of Registration
- Sweden EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
Single Use
Yes
Implantable
No
Reusable
No
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
No
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
Yes
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Dimensions & Sizes
- Size
- Length — 40 Centimeter FDA UDICatheter Gauge — 16 French FDA UDI
Category: Urethral dilatation catheter, non-medicated
Dila-Cath Nelaton 40cm CH16 by Wellspect AB — Class I — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (2 countries)
Regulatory Authorizations
MDR
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 c1b546d6-22c3-4bd3-88c7-7ec55ee0d46e 37 fields · synced Jul 11, 2026
- EUDAMED 15d52cc8-5f6a-4168-995d-3dd7a36b3cd6 61 fields · synced Jul 11, 2026