Taiwan FDA registration 9db4d4488124b5546b46cc7722745ba3
"X-Smart Plus" Dental Operative Unit and Accessories (Non-Sterile)
TW: "愛克絲斯馬特普臘斯" 牙科手術裝置及其附件 (未滅菌)
Registration details
- Analysis ID
- 9db4d4488124b5546b46cc7722745ba3
- License Form
- Ministry of Health Medical Device Import No. 018004
- Customs Code
- DHA09401800401
Company information
- Manufacturer
- MAILLEFER INSTRUMENTS HOLDING SARL
- Manufacturer Country
- Switzerland
- Authorized Representative
- DENTSPLY SIRONA INC., TAIWAN BRANCH (U.S.A.)
Product details
- Intended Use
- Limited to the first level identification range of dental surgical devices and their accessories (F.6640) under the Measures for the Administration of Medical Devices.
- Product Type (Level 1)
- F Dental devices
- Product Type (Level 2)
- F6640 Dental Surgical Devices and Their Accessories
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jun 22, 2017
- Expiry Date
- Jun 22, 2022
About this record
Access comprehensive regulatory information for "X-Smart Plus" Dental Operative Unit 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 9db4d4488124b5546b46cc7722745ba3 and manufactured by MAILLEFER INSTRUMENTS HOLDING SARL. The authorized representative in Taiwan is DENTSPLY SIRONA INC., TAIWAN BRANCH (U.S.A.).
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