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 offers three Smart Electrode sizes to accommodate different treatment areas and clinical workflows.
Smart Electrode M
Approx. 224 × 237 mm Max. output 150 W
Smart Electrode L
Approx. 348 × 351 mm Max. output 250 W
Smart Electrode XL
Approx. 450 × 350 mm Max. output 350 W
Electrode selection, treatment site, and parameter settings should be determined by appropriately trained healthcare professionals based on each patient’s individual condition.