Taiwan FDA registration 389613243537638c841152688d90f8d1
“BIOTRONIK”AlCath Force Sensing Ablation Catheter
TW: “百多力”力感測式消融導管
Taiwan·Risk Class 3·MD·ACUTUS MEDICAL, INC·Registered Apr 21, 2022 – Apr 21, 2027ActiveRegistration details
- Analysis ID
- 389613243537638c841152688d90f8d1
- License Form
- Ministry of Health Medical Device Import No. 035407
- Customs Code
- DHA05603540700
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)
- E0008 Percutaneous puncture of cardiac ablation system
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Apr 21, 2022
- Expiry Date
- Apr 21, 2027
About this record
Access comprehensive regulatory information for “BIOTRONIK”AlCath Force Sensing Ablation Catheter in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 389613243537638c841152688d90f8d1 and manufactured by ACUTUS MEDICAL, INC. The authorized representative in Taiwan is BIOTRONIK TAIWAN LIMITED.
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