Taiwan FDA registration 3c9a973c10975af4328e7793de7d7aeb
“AItewan” DeepBT Detector
TW: “智德萬”人工智慧腦瘤輔助偵測系統
Taiwan·Risk Class 2·MD·EBM TECHNOLOGIES INCORPORATED·Registered Jul 21, 2023 – Jul 21, 2028ActiveRegistration details
- Analysis ID
- 3c9a973c10975af4328e7793de7d7aeb
- License Form
- Ministry of Health Medical Device Manufacturing No. 007906
Company information
- Manufacturer
- EBM TECHNOLOGIES INCORPORATED
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- National Yangming Jiaotong University (Innovative Medical Materials Translation R&D Center)
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P2050 Medical Image Management and Processing System
- Import Information
- Produced in Taiwan, China; Contract manufacturing
Dates and status
- Registration Date
- Jul 21, 2023
- Expiry Date
- Jul 21, 2028
About this record
Access comprehensive regulatory information for “AItewan” DeepBT Detector in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3c9a973c10975af4328e7793de7d7aeb and manufactured by EBM TECHNOLOGIES INCORPORATED. The authorized representative in Taiwan is National Yangming Jiaotong University (Innovative Medical Materials Translation R&D Center).
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