Identity
- Trade Name
- VIVA RF electrode EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
- Device Name
- VIVA RF electrode EUDAMEDThe VIVA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing. FDA UDI
- Model / Reference
- 15-20V05-30X_V2 EUDAMEDFDA UDI
- Description
- The VIVA RF Electrode is a sterile, single-use electrosurgical accessory intended to be used in conjunction with VIVA combo RF Generator. This electrode comprises an electrode tip, handle and tubing. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809306763440 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809306763440 EUDAMED880930676VIVA_EWD EUDAMED
- FDA Product Code
- GEI FDA UDI
- EMDN Code
- K0201010301 OPEN ELECTROSURGERY ELECTRODES, SINGLE-USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 878.4400 FDA UDI
- Market of Registration
- France EUDAMEDBulgaria 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
Yes
Dimensions & Sizes
- Size
- Needle Gauge — 15 Gauge FDA UDILength — 20 Centimeter FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
VIVA RF electrode by Starmed Co., Ltd — Class IIb — MDR, MDD, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Open-surgery electrosurgical electrode, monopolar, single-use.
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Authorization Coverage (2 countries)
Regulatory Authorizations
CE/MDR
CE/MDD
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | B-08809306763440 | Class IIb | Active |
| EUDAMED | European Union | CE/MDD | B-08809306763440 | 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 (3)
- EUDAMED d2da2174-2062-4ae0-ba2b-3287c6c10f4d 61 fields · synced Jul 13, 2026
- EUDAMED 1b8cfcf2-c772-434b-93a7-c8724c6b1744 61 fields · synced May 18, 2026
- FDA UDI b53ed6b0-8252-4c30-8656-3fd1ac765fb3 36 fields · synced May 30, 2026