Taiwan FDA registration 3dcb705c7a326b34ef768863f0bea3c9
“Leadtek” Wearable Oximetry Monitor
TW: “麗臺” 穿戴式血氧監測儀
Taiwan·Risk Class 2·MD·LEADTEK RESEARCH, INC.·Registered Aug 19, 2023 – Aug 19, 2028ActiveRegistration details
- Analysis ID
- 3dcb705c7a326b34ef768863f0bea3c9
- License Form
- Ministry of Health Medical Device Manufacturing No. 007964
Company information
- Manufacturer
- LEADTEK RESEARCH, INC.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- LEADTEK RESEARCH, INC.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E2700 Oximeter
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Aug 19, 2023
- Expiry Date
- Aug 19, 2028
About this record
Access comprehensive regulatory information for “Leadtek” Wearable Oximetry Monitor in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3dcb705c7a326b34ef768863f0bea3c9 and manufactured by LEADTEK RESEARCH, INC.. The authorized representative in Taiwan is LEADTEK RESEARCH, INC..
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