Taiwan FDA registration 456f3748073211b29451b55edb862c2d
“SJM” Quadra Assura Implantable Cardioverter Defibrillator
TW: “聖猷達”克卓亞速拉植入式心律去顫器
Registration details
- Analysis ID
- 456f3748073211b29451b55edb862c2d
- License Form
- Ministry of Health Medical Device Import No. 028256
- Customs Code
- DHA05602825601
Company information
- Manufacturer
- ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD.
- Manufacturer Country
- Malaysia
- Authorized Representative
- Abbott Medical Taiwan Co.
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E3610 Pulse generator for implantable heart rhythm apparatus
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 11, 2016
- Expiry Date
- Mar 11, 2026
About this record
Access comprehensive regulatory information for “SJM” Quadra Assura Implantable Cardioverter Defibrillator in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 456f3748073211b29451b55edb862c2d and manufactured by ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD.. The authorized representative in Taiwan is Abbott Medical Taiwan Co..
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