Taiwan FDA registration 59c59cce20cb5b37cc844157cd251a9c
“BIOTRONIK” AcQMap High Resolution Imaging and Mapping System
TW: “百多力”艾科心臟電生理影像及定位系統
Taiwan·Risk Class 2·MD·ACUTUS MEDICAL, INC·Registered Feb 16, 2022 – Feb 16, 2027ActiveRegistration details
- Analysis ID
- 59c59cce20cb5b37cc844157cd251a9c
- License Form
- Ministry of Health Medical Device Import No. 035309
- Customs Code
- DHA05603530900
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 16, 2022
- Expiry Date
- Feb 16, 2027
About this record
Access comprehensive regulatory information for “BIOTRONIK” AcQMap High Resolution Imaging and Mapping System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 59c59cce20cb5b37cc844157cd251a9c and manufactured by ACUTUS MEDICAL, INC. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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