Identity
- Trade Name
- VIVA combo RF Generator EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- VIVA combo RF Generator EUDAMEDThe VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This generator monitors the power, resistance, current and temperature. FDA UDI
- Model / Reference
- VCS10 EUDAMEDFDA UDI
- Description
- The VIVA combo RF System consists of RF generator, active electrode, grounding pad and peristaltic pump for electrode cooling. This device is designed to produce local tissue heating at the tip of the electrodes causing the coagulation and ablation of tissue. The VIVA combo RF System is capable of delivering up to 200 W of RF power and the available power is limited through software control. This generator monitors the power, resistance, current and temperature. FDA UDI
Identifiers
- Catalog Number
- VCS10 FDA UDI
- Primary DI / UDI-DI
- 08809306769152 EUDAMEDFDA UDI
- Basic UDI-DI
- 880930676VIVAcombo_GEN EUDAMED
- 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
- Bulgaria 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
Dimensions & Sizes
- Size
- Width — 260 Millimeter FDA UDILength — 348 Millimeter FDA UDIHeight — 115 Millimeter FDA UDIWeight — 6 Kilogram FDA UDI
Category: Foot-switch, electrical
VIVA combo RF Generator by Starmed Co., Ltd — Class IIb — MDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
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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 | 880930676VIVAcombo_GEN | Class IIb | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class IIb | Pending data |
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Manufacturer
- Manufacturer
- STARmed Co., Ltd.
- EUDAMED SRN
- KR-MF-000008605
- Authorised Representative
- Emergo Europe B.V. NL-AR-000000116
Sources (2)
- EUDAMED 4f4351a5-df83-482e-9990-0da1d695461d 61 fields · synced Jul 19, 2026
- FDA UDI b05b38db-cf99-4278-8436-76382f6013c6 37 fields · synced May 30, 2026