“COLTENE” HyFlex File (non-sterile) - Taiwan Registration 03e370853d43df6b456969ae75032919
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..
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.
Device Details
Registration Details
03e370853d43df6b456969ae75032919
Ministry of Health Medical Device Import No. 021693
DHA09402169308
Product Details
Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Dental Hand Instruments (F.4565)".
F Dental devices
F4565 Hand instruments for dental use
Imported from abroad
Dates and Status
Jul 03, 2020
Jul 03, 2025

