Taiwan FDA registration 1140b38a7126de19fbe6a5a6f9111d8c
“BIOTRONIK”Qubic Force Sensing Module
TW: “百多力”柯比思力感測顯示儀
Taiwan·Risk Class 2·MD·ACUTUS MEDICAL, INC·Registered Feb 22, 2022 – Feb 22, 2027ActiveRegistration details
- Analysis ID
- 1140b38a7126de19fbe6a5a6f9111d8c
- License Form
- Ministry of Health Medical Device Import No. 035312
- Customs Code
- DHA05603531202
Company information
- Manufacturer
- ACUTUS MEDICAL, INC
- Manufacturer Country
- United States
- Authorized Representative
- BIOTRONIK TAIWAN LIMITED
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E1425 Programmable diagnostic PC
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 22, 2022
- Expiry Date
- Feb 22, 2027
About this record
Access comprehensive regulatory information for “BIOTRONIK”Qubic Force Sensing Module in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 1140b38a7126de19fbe6a5a6f9111d8c and manufactured by ACUTUS MEDICAL, INC. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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