Taiwan FDA registration 8e985b733272a04c691627598b1b1c3b
“Prevena” Incision Management System
TW: “佩威”術後傷口照護系統
Taiwan·Risk Class 2·MD·KCI USA, Inc.;;KCI Manufacturing·Registered Jan 19, 2017 – Jan 19, 2027ActiveRegistration details
- Analysis ID
- 8e985b733272a04c691627598b1b1c3b
- License Form
- Ministry of Health Medical Device Import No. 028810
- Customs Code
- DHA05602881001
Company information
- Manufacturer
- KCI USA, Inc.;;KCI Manufacturing
- Manufacturer Country
- United States;;Ireland
- Authorized Representative
- 3M TAIWAN LTD.
Product details
- Intended Use
- To treat surgical incisions that still leak to the outside after sutures or staples, wound negative pressure therapy techniques are used to provide a closed environment and remove exudate.
- Product Type (Level 1)
- I General and plastic surgical devices
- Product Type (Level 2)
- I4780 powered suction pump
- Import Information
- Imported from abroad; Contract manufacturing
Dates and status
- Registration Date
- Jan 19, 2017
- Expiry Date
- Jan 19, 2027
About this record
Access comprehensive regulatory information for “Prevena” Incision Management System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 8e985b733272a04c691627598b1b1c3b and manufactured by KCI USA, Inc.;;KCI Manufacturing. The authorized representative in Taiwan is 3M TAIWAN LTD..
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