Taiwan FDA registration e26663e0441fbfceedf0aee1673a1576
"Ambu" Medical Imaging Communication Device and Accessories (Non-sterilized)
TW: "安佈" 醫學影像通訊裝置及其附件 (未滅菌)
Taiwan·Risk Class 1·AMBU A/S;; 百視美股份有限公司·Registered Aug 29, 2023 – Aug 29, 2028ActiveRegistration details
- Analysis ID
- e26663e0441fbfceedf0aee1673a1576
- Customs Code
- DHA09300992905
Company information
- Manufacturer
- AMBU A/S;; 百視美股份有限公司
- Manufacturer Country
- Taiwan, Province of China;;Denmark
- Authorized Representative
- HWA YI MEDICAL CO., LTD.
Product details
- Intended Use
- It is limited to the scope of first-level identification of medical imaging communication devices (P.2020) in the Measures for the Classification and Grading of Medical Devices.
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.2020 Medical imaging communication devices
- Import Information
- Contract manufacturing;; QMS/QSD;; Domestic;; Foreign commissioned domestic manufacturing, and then unified by foreign imports
Dates and status
- Registration Date
- Aug 29, 2023
- Expiry Date
- Aug 29, 2028
About this record
Access comprehensive regulatory information for "Ambu" Medical Imaging Communication Device and Accessories (Non-sterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number e26663e0441fbfceedf0aee1673a1576 and manufactured by AMBU A/S;; 百視美股份有限公司. The authorized representative in Taiwan is HWA YI MEDICAL CO., LTD..
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