Taiwan FDA registration 3aeaa34bef94100cbfeef967c8215396

“Merit” StabiliT MX Vertebral Augmentation System with PowerCurve Navigating Osteotome

TW: “美瑞特”史達挺椎體增強骨水泥系統暨力量曲度導航骨刀
Taiwan flagTaiwan·Risk Class 2·MD·Merit Medical Systems, Inc.·Registered Aug 18, 2022 – Aug 18, 2027Active
Registration details
Analysis ID
3aeaa34bef94100cbfeef967c8215396
License Form
Ministry of Health Medical Device Import No. 035744
Customs Code
DHA05603574405
Company information
Manufacturer Country
United States
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
N Orthopedics
Product Type (Level 2)
N3027 PMMA bone cement
Import Information
Imported from abroad
Dates and status
Registration Date
Aug 18, 2022
Expiry Date
Aug 18, 2027
About this record

Access comprehensive regulatory information for “Merit” StabiliT MX Vertebral Augmentation System with PowerCurve Navigating Osteotome in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3aeaa34bef94100cbfeef967c8215396 and manufactured by Merit Medical Systems, Inc.. The authorized representative in Taiwan is Merit Medical Asia Company Limited Taiwan Branch (Hong Kong).

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