Taiwan FDA registration 421af659bb5c819cd1b349dfbe3038e0
"Ultraimage" ultrasound imager
TW: “超象”超音波影像儀
Registration details
- Analysis ID
- 421af659bb5c819cd1b349dfbe3038e0
Company information
- Manufacturer
- Dal Biotechnology Co., Ltd. Zhongli Plant
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- LELTEK INC.
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.1550 Ultrasonic pulsating Duppler imaging system
- Import Information
- Contract manufacturing;; Domestic
Dates and status
- Registration Date
- May 07, 2020
- Expiry Date
- May 07, 2025
About this record
Access comprehensive regulatory information for "Ultraimage" ultrasound imager in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 421af659bb5c819cd1b349dfbe3038e0 and manufactured by Dal Biotechnology Co., Ltd. Zhongli Plant. The authorized representative in Taiwan is LELTEK INC..
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