Identity
- Trade Name
- star RF electrode-Fixed EUDAMEDstar RF Electrode EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation probe, tumour-ablation, monopolar FDA UDI
- Device Name
- star RF electrode-Fixed EUDAMEDstar RF Electrode EUDAMEDThe star 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
- 18-07s07F EUDAMEDFDA UDI
- Description
- The star 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
- Catalog Number
- 18-07s07F FDA UDI
- Primary DI / UDI-DI
- 08809306760050 EUDAMEDFDA UDI
- Basic UDI-DI
- B-08809306760050 EUDAMED880930676star_EVG EUDAMED
- 510(k) Number
- K172012 FDA UDI
- 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 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 — 18 Gauge FDA UDILength — 7 Centimeter FDA UDI
Category: Open-surgery electrosurgical electrode, monopolar, single-use
star RF electrode-Fixed by Starmed Co., Ltd — Class IIb — MDD, MDR, 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/MDD
CE/MDR
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDD | B-08809306760050 | Class IIb | Active |
| EUDAMED | European Union | CE/MDR | B-08809306760050 | 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 4ee42b51-e16e-4253-aa7b-7f32e0f83ebe 61 fields · synced Jul 23, 2026
- EUDAMED b43fd79d-c708-4b48-b15f-8deecfd2b8ef 61 fields · synced May 17, 2026
- FDA UDI 2b52c4de-bd68-4c34-ab58-8be606ca6d3c 38 fields · synced May 30, 2026