Taiwan FDA registration b8fbc1066019bcfc422068c1dc45e324
Outhian Intraoral gel (unsterilized)
TW: 歐蒂安 口內凝膠 (未滅菌)
Taiwan·Risk Class 1·CORELEADER BIOTECH CO., LTD.·Registered Nov 24, 2015 – Nov 24, 2025ExpiredRegistration details
- Analysis ID
- b8fbc1066019bcfc422068c1dc45e324
Company information
- Manufacturer
- CORELEADER BIOTECH CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- PHARMA POWER BIOTEC CO., LTD.
Product details
- Intended Use
- Limited to the first level identification range of the "Liquid Bandage (J.5090)" Classification and Grading Management Measures for Medical Equipment.
- Product Type (Level 1)
- J General hospital and personal use equipment
- Product Type (Level 2)
- J.5090 Liquid bandages
- Import Information
- Contract manufacturing;; Domestic
Dates and status
- Registration Date
- Nov 24, 2015
- Expiry Date
- Nov 24, 2025
About this record
Access comprehensive regulatory information for Outhian Intraoral gel (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b8fbc1066019bcfc422068c1dc45e324 and manufactured by CORELEADER BIOTECH CO., LTD.. The authorized representative in Taiwan is PHARMA POWER BIOTEC CO., LTD..
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