Taiwan FDA registration 979da35dbd4e3b2013fe486e36cf6bd9
“Leadtek”amor H3 Plus Patch
TW: “麗臺”心電心音記錄器
Taiwan·Risk Class 2·MD·LEADTEK RESEARCH, INC.·Registered Oct 29, 2022 – Oct 29, 2027ActiveRegistration details
- Analysis ID
- 979da35dbd4e3b2013fe486e36cf6bd9
- License Form
- Ministry of Health Medical Device Manufacturing No. 007760
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)
- E2340 ECG Scanner
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Oct 29, 2022
- Expiry Date
- Oct 29, 2027
About this record
Access comprehensive regulatory information for “Leadtek”amor H3 Plus Patch in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 979da35dbd4e3b2013fe486e36cf6bd9 and manufactured by LEADTEK RESEARCH, INC.. The authorized representative in Taiwan is LEADTEK RESEARCH, INC..
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