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 (please refer to the latest TFDA record) Download Medical Device License
- Approved Manual Version
- Please refer to the full approved Chinese manual, available for download below Download TFDA-Approved Manual (Chinese)
Product & License Information
- Product Name (Taiwan-approved): 「安可盛」腫瘤電熱治療儀
- English Name: OncoTherm Oncological Electro-Hyperthermia Device
- Model: EHY-2030
- Medical Device License No.: TFDA Import License No. 038205
- Manufacturer: OncoTherm Kft. (Hungary)
- Taiwan Distributor: Elixgene Biotech LTD.（礫晶有限公司）
TFDA-Approved Manual (Chinese)
To ensure information is complete and not misleading, this site only publishes the full text of the TFDA-approved Chinese manual — never an excerpt.
📄 Download the TFDA-Approved Manual (Chinese, PDF)
Medical Device License
📄 Download the Medical Device License (PDF)
The intended use, indications, contraindications, warnings, and precautions of this medical device are governed by the latest label and manual approved by Taiwan’s Ministry of Health and Welfare. Where any other page on this site differs from the approved manual, the approved manual prevails.