Taiwan FDA registration 9da5ab11f1891f7055b097ace8a221aa

"ROMANA" Orthodontic appliance and accessories (Non-Sterile)

TW: "皓美" 牙科矯正裝置及其附件 (未滅菌)

Taiwan·Risk Class 1·MD·ORTHOACCEL TECHNOLOGIES, INC.·Registered Mar 16, 2016 – Mar 16, 2021Expired

Registration details

Analysis ID: 9da5ab11f1891f7055b097ace8a221aa
License Form: Ministry of Health Medical Device Import No. 016270
Customs Code: DHA09401627002

Company information

Manufacturer: ORTHOACCEL TECHNOLOGIES, INC.
Manufacturer Country: United States
Authorized Representative: ROMANA ENTERPRISES LTD.

Product details

Intended Use: Limited to the first-level identification scope of the Measures for the Administration of Medical Devices "Dental Orthodontic Devices and Their Accessories (F.5410)".
Product Type (Level 1): F Dental devices
Product Type (Level 2): F5410 Dental Orthodontic Devices and Their Accessories
Import Information: Imported from abroad

Dates and status

Registration Date: Mar 16, 2016
Expiry Date: Mar 16, 2021

About this record

Access comprehensive regulatory information for "ROMANA" Orthodontic appliance and accessories (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 9da5ab11f1891f7055b097ace8a221aa and manufactured by ORTHOACCEL TECHNOLOGIES, INC.. The authorized representative in Taiwan is ROMANA ENTERPRISES LTD..

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