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Endovenous Radiofrequency Generator
EUDAMEDFDA UDIClass IIb (EU MDR)
Ref JM-S40
Identity
- Trade Name
- Curaway FDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- Endovenous Radiofrequency Generator EUDAMEDFDA UDI
- Model / Reference
- JM-S40 EUDAMEDFDA UDI
- Description
- Endovenous Radiofrequency Generator FDA UDI
Identifiers
- Primary DI / UDI-DI
- 06936666506072 EUDAMED06936666559269 FDA UDI
- Basic UDI-DI
- 69366665JMF7M EUDAMED
- 510(k) Number
- K232505 FDA UDI
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation system generator 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
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
Yes
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
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
Yes
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Foot-switch, electrical
Endovenous Radiofrequency Generator 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
European Union Active
CE/MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 69366665JMF7M | 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 e333bdaa-ab18-4d4f-a734-e4278c027fc2 61 fields · synced May 31, 2026
- FDA UDI 0fceeb4c-4a21-4634-b0d3-23db0d873c26 34 fields · synced May 30, 2026