Taiwan FDA registration f61d1581ce67fbac79620849dfda73c8
“BIOTRONIK” SentiCath 3D Imaging and Mapping Catheter
TW: “百多力”聖凱斯心臟電生理影像及定位導管
Taiwan·Risk Class 2·MD·ACUTUS MEDICAL, INC·Registered Mar 16, 2022 – Mar 16, 2027ActiveRegistration details
- Analysis ID
- f61d1581ce67fbac79620849dfda73c8
- License Form
- Ministry of Health Medical Device Import No. 035325
- Customs Code
- DHA05603532501
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)
- E1220 electrode recording catheter or electrode recording probe
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 16, 2022
- Expiry Date
- Mar 16, 2027
About this record
Access comprehensive regulatory information for “BIOTRONIK” SentiCath 3D Imaging and Mapping Catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number f61d1581ce67fbac79620849dfda73c8 and manufactured by ACUTUS MEDICAL, INC. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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