Regulatory Information
- Taiwan-Approved Product Name
- OncoTherm Oncological Electro-Hyperthermia Device（「安可盛」腫瘤電熱治療儀）
- License Number
- TFDA Import License No. 038205
- License Status
- Active (issued 2025-08-03, valid through 2030-08-03; please refer to the latest TFDA record) Download Medical Device License
- Approved Manual Version
- Approved concurrently with the medical device license; the manual itself carries no separate version number (refer to the full approved manual for the authoritative text)（2025-08-03） Download TFDA-Approved Manual (Chinese)
The EHY-2030 is an oncological electro-hyperthermia device developed by OncoTherm. The table below lists its full technical specifications; the approved Chinese manual and the manufacturer’s latest technical documentation take precedence over this page.
Technical Specifications
| Item | Specification |
|---|---|
| Model | EHY-2030 |
| Power Supply | 100–230 V / 50–60 Hz |
| Max. Power Consumption | 800 W |
| Max. RF Output | 800 Wpp |
| Rated Effective RF Output | 350 Weff |
| Adjustable Power Range | 25–350 W |
| RF Operating Frequency | 13.56 MHz |
| Treatment Duration | 1–90 minutes (adjustable) |
| Dimensions | 2500 × 1150 × 1350 mm |
| Weight | Approx. 200 kg |
| Interface | LCD touchscreen |
| Electrode System | Smart Electrode System (M / L / XL) |
| Patient Management System | Integrated PMS-100 |
Please refer to the TFDA-approved manual and the manufacturer’s latest technical documentation for the authoritative specifications and operating procedures. In case of any discrepancy, the approved manual governs.