Taiwan FDA registration 35baf175f9cf96c64b011d928aab23e3
HEVABIO Hydrocolloid Dressing (Sterile)
TW: 適膚保 親水性敷料(滅菌)
Taiwan·Risk Class 1·MD·CORELEADER BIOTECH CO., LTD.·Registered Dec 19, 2018 – Dec 19, 2023ExpiredRegistration details
- Analysis ID
- 35baf175f9cf96c64b011d928aab23e3
- License Form
- Ministry of Health Medical Device Manufacturing No. 007579
Company information
- Manufacturer
- CORELEADER BIOTECH CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- CORELEADER BIOTECH CO., LTD.
Product details
- Intended Use
- Limited to the first-level identification range of the Measures for the Administration of Medical Devices "Hydrophilic Wound Covering Materials (I.4018)".
- Product Type (Level 1)
- I General and plastic surgical devices
- Product Type (Level 2)
- I4018 Hydrophilic trauma coverings
- Import Information
- Produced in Taiwan, China; GMP
Dates and status
- Registration Date
- Dec 19, 2018
- Expiry Date
- Dec 19, 2023
About this record
Access comprehensive regulatory information for HEVABIO Hydrocolloid Dressing (Sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 35baf175f9cf96c64b011d928aab23e3 and manufactured by CORELEADER BIOTECH CO., LTD.. The authorized representative in Taiwan is CORELEADER BIOTECH CO., LTD..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices