Taiwan FDA registration 5b4e918ef8e8f8a58e8e41e95622c6aa
"Ultraimage" handheld ultrasound imaging system
TW: 〝超象〞手持式超音波影像系統
Taiwan·Risk Class 2·Zhubei Industrial Co., Ltd·Registered Aug 11, 2021 – Aug 11, 2026ActiveRegistration details
- Analysis ID
- 5b4e918ef8e8f8a58e8e41e95622c6aa
Company information
- Manufacturer
- Zhubei Industrial Co., Ltd
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- LELTEK INC.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.1550 Ultrasonic pulsating Duppler imaging system
- Import Information
- Domestic;; Contract manufacturing
Dates and status
- Registration Date
- Aug 11, 2021
- Expiry Date
- Aug 11, 2026
About this record
Access comprehensive regulatory information for "Ultraimage" handheld ultrasound imaging system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 5b4e918ef8e8f8a58e8e41e95622c6aa and manufactured by Zhubei Industrial Co., Ltd. The authorized representative in Taiwan is LELTEK INC..
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