Taiwan FDA registration 3f971e102d01fe8c48abd4dc4273d73b

"OMKO" dental orthodontic devices and their accessories (unsterilized)

TW: "歐姆可" 牙科矯正裝置及其附件 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·ORMCO CORPORATION;;ORMEX, S. DE R.L. DE C.V.·Registered Jun 24, 2011 – Jun 24, 2026Expired
Registration details
Analysis ID
3f971e102d01fe8c48abd4dc4273d73b
Customs Code
DHA04401051302
Company information
Manufacturer Country
Mexico;;United States
Authorized Representative
YONG CHIEH ENTERPRISE CO., LTD.
Product details
Intended Use
Limited to the first level identification range of medical equipment classification and grading management measures, dental orthodontic devices and their accessories (F.5410).
Product Type (Level 1)
F Dentistry
Product Type (Level 2)
F.5410 Dental orthodox equipment and accessories thereof
Import Information
Contract manufacturing;; input
Dates and status
Registration Date
Jun 24, 2011
Expiry Date
Jun 24, 2026
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About this record

Access comprehensive regulatory information for "OMKO" dental orthodontic devices and their accessories (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3f971e102d01fe8c48abd4dc4273d73b and manufactured by ORMCO CORPORATION;;ORMEX, S. DE R.L. DE C.V.. The authorized representative in Taiwan is YONG CHIEH ENTERPRISE CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 3 companies making similar products including ORMEX S. DE R.L DE C.V.;;Ormco Corporation, Ormco Corporation, and 3 recent registrations in the same category. 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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