- 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 system includes a treatment platform, RF system, control interface, and Smart Electrodes, with electrode size selected according to clinical needs.
Key System Components
Smart Electrode System
The EHY-2030 offers Smart Electrodes in multiple sizes (M / L / XL), selected by healthcare professionals according to the treatment area and clinical workflow. See Electrodes & Accessories.
Integrated Treatment Platform
The system integrates a patient treatment platform, RF energy system, electrode positioning mechanism, and control interface to support professional operation in a clinical setting.
Professional Medical Use
The EHY-2030 must be operated by a physician and/or appropriately trained clinical staff, under a physician’s direction.
Electrodes & Accessories
The EHY-2030 offers three Smart Electrode sizes to accommodate different …
Learn more →TFDA Approval
Product & License Information Product Name (Taiwan-approved): 「安可盛」腫瘤電熱治療儀 …
Learn more →Important Safety Information
The EHY-2030 is a professional medical device. It must be operated by a …
Learn more →