Taiwan FDA registration 0582bd58ad632b65a46fb310c77f992f
PULSTA Transcatheter Pulmonary Valve
TW: 柏世大經導管肺動脈瓣膜
Taiwan·Risk Class 3·MD·TAEWOONG MEDICAL CO., LTD.·Registered Dec 20, 2022 – Dec 20, 2027ActiveRegistration details
- Analysis ID
- 0582bd58ad632b65a46fb310c77f992f
- License Form
- Ministry of Health Medical Device Import No. 034627
- Customs Code
- DHA05603462709
Company information
- Manufacturer
- TAEWOONG MEDICAL CO., LTD.
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- Xintech medical co., Ltd.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- E Cardiovascular Medicine Science
- Product Type (Level 2)
- E3925 Heart valve replacement
- Import Information
- Imports outside the borders;; Safety monitoring
Dates and status
- Registration Date
- Dec 20, 2022
- Expiry Date
- Dec 20, 2027
About this record
Access comprehensive regulatory information for PULSTA Transcatheter Pulmonary Valve in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 3 medical device is registered under number 0582bd58ad632b65a46fb310c77f992f and manufactured by TAEWOONG MEDICAL CO., LTD.. The authorized representative in Taiwan is Xintech medical co., Ltd..
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