Endovenous Radiofrequency Catheter
EUDAMEDFDA UDIClass IIb (EU MDR)
Identity
- Trade Name
- Curaway FDA UDI
- Generic Name
- Peripheral vascular electrocautery catheter, single-use FDA UDI
- Device Name
- Endovenous Radiofrequency Catheter EUDAMEDFDA UDI
- Model / Reference
- CFB 2.3-7-60 EUDAMEDFDA UDI
- Description
- Endovenous Radiofrequency Catheter FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936666528043 EUDAMED06936666559320 FDA UDI
- Basic UDI-DI
- 69366665CFH4 EUDAMED
- 510(k) Number
- K232505 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K02030199 RADIOFREQUENCY SURGERY INSTRUMENTS, SINGLE-USE - OTHER EUDAMED
- GMDN Term
- Peripheral vascular electrocautery catheter, single-use FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- Germany 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
No
Lot / Batch Number
Yes
Serial Number
No
Expiration Date
Yes
Manufacturing Date
No
Category: Microwave ablation system probe, non-powered
Endovenous Radiofrequency Catheter by Zhejiang CuraWay Medical Technology Co., Ltd. — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69366665CFH4 | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- Zhejiang CuraWay Medical Technology Co., Ltd.
- EUDAMED SRN
- CN-MF-000025983
- Authorised Representative
- Prolinx GmbH DE-AR-000005129
Sources (2)
- EUDAMED 436b28fa-7ae3-4403-86a5-177f0d1d3a4a 61 fields · synced Aug 4, 2026
- FDA UDI f1b0eecb-4867-4a12-843b-f7698f314476 34 fields · synced May 30, 2026