Taiwan FDA registration 097ac57d67325b5d609ca35ab894a380
“Coltène/Whaledent” Speedex Impression Material
TW: “康特”極速印模材料
Registration details
- Analysis ID
- 097ac57d67325b5d609ca35ab894a380
- License Form
- Ministry of Health Medical Device Import No. 035356
- Customs Code
- DHA05603535609
Company information
- Manufacturer
- COLTENE/WHALEDENT AG
- Manufacturer Country
- Switzerland
- Authorized Representative
- HEALTHY MEDICAL & TEXTILE CO., LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- F Dentistry
- Product Type (Level 2)
- F3660 impression material
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 22, 2022
- Expiry Date
- Mar 22, 2027
About this record
Access comprehensive regulatory information for “Coltène/Whaledent” Speedex Impression Material in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 097ac57d67325b5d609ca35ab894a380 and manufactured by COLTENE/WHALEDENT AG. The authorized representative in Taiwan is HEALTHY MEDICAL & TEXTILE 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