Taiwan FDA registration de025361325fe3c6c16e4a1a7afdd726
“Abbott”Zenex Pulse Generator
TW: “雅培”戰神心臟節律器
Taiwan·Risk Class 3·MD·ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD.·Registered Feb 28, 2023 – Feb 28, 2028ActiveRegistration details
- Analysis ID
- de025361325fe3c6c16e4a1a7afdd726
- License Form
- Ministry of Health Medical Device Import No. 036322
- Customs Code
- DHA05603632200
Company information
- Manufacturer
- ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD.
- Manufacturer Country
- Malaysia
- Authorized Representative
- Abbott Medical Taiwan Co.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E3610 Pulse generator for implantable heart rhythm apparatus
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 28, 2023
- Expiry Date
- Feb 28, 2028
About this record
Access comprehensive regulatory information for “Abbott”Zenex Pulse Generator in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number de025361325fe3c6c16e4a1a7afdd726 and manufactured by ST. JUDE MEDICAL OPERATIONS (M) SDN. BHD.. The authorized representative in Taiwan is Abbott Medical Taiwan Co..
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