Taiwan FDA registration 03e370853d43df6b456969ae75032919
“COLTENE” HyFlex File (non-sterile)
TW: “柯汀” 海孚根管銼針(未滅菌)
Taiwan·Risk Class 1·MD·COLTENE / WHALEDENT, INC.·Registered Jul 03, 2020 – Jul 03, 2025ExpiredRegistration details
- Analysis ID
- 03e370853d43df6b456969ae75032919
- License Form
- Ministry of Health Medical Device Import No. 021693
- Customs Code
- DHA09402169308
Company information
- Manufacturer
- COLTENE / WHALEDENT, INC.
- Manufacturer Country
- United States
- Authorized Representative
- LEADING WAVE RA CO., LTD.
Product details
- Intended Use
- Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Dental Hand Instruments (F.4565)".
- Product Type (Level 1)
- F Dental devices
- Product Type (Level 2)
- F4565 Hand instruments for dental use
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 03, 2020
- Expiry Date
- Jul 03, 2025
About this record
Access comprehensive regulatory information for “COLTENE” HyFlex File (non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 03e370853d43df6b456969ae75032919 and manufactured by COLTENE / WHALEDENT, INC.. The authorized representative in Taiwan is LEADING WAVE RA CO., LTD..
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