Taiwan FDA registration 1dbfafe144c93338f92a38640796f94a
"Bharti Tom" CT scanner
TW: “巴帝湯姆” 電腦斷層掃描儀
Taiwan·Risk Class 2·Neurologica Corporation (Subsidiary of Samsung Electronics)·Registered Mar 23, 2024 – Mar 23, 2029ActiveRegistration details
- Analysis ID
- 1dbfafe144c93338f92a38640796f94a
- Customs Code
- DHAS5603695801
Company information
- Manufacturer Country
- United States
- Authorized Representative
- SUMTAGE ENTERPRISE CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.1750 電腦斷層掃描X光系統
- Import Information
- The consent of the Nuclear Safety Commission must be obtained for each import of this medical device.;; Input;; The use of this device shall comply with the provisions of the Administrative Measures for the Implementation or Use of Medical Devices for Specific Medical Technology Inspection and Testing.
Dates and status
- Registration Date
- Mar 23, 2024
- Expiry Date
- Mar 23, 2029
About this record
Access comprehensive regulatory information for "Bharti Tom" CT scanner in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1dbfafe144c93338f92a38640796f94a and manufactured by Neurologica Corporation (Subsidiary of Samsung Electronics). The authorized representative in Taiwan is SUMTAGE ENTERPRISE CO., LTD..
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