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“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.

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03e370853d43df6b456969ae75032919
Registration Details
Taiwan FDA Registration: 03e370853d43df6b456969ae75032919
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Device Details

“COLTENE” HyFlex File (non-sterile)
TW: “柯汀” 海孚根管銼針(未滅菌)
Risk Class 1
MD

Registration Details

03e370853d43df6b456969ae75032919

Ministry of Health Medical Device Import No. 021693

DHA09402169308

Company Information

United States

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