Taiwan FDA registration 7a3043e528486bf8941966037d4e1be9

"Megaspine" MIS instruments for spinal internal fixation (Non-Sterile)

TW: "兆峰" 脊柱微創手術器械 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·CHANGZHOU CONDYN MEDICAL INSTRUMENT CO.,LTD;;MEGASPINE MEDICAL CO., LTD.·Registered Jul 30, 2018 – Jul 30, 2028Active
Registration details
Analysis ID
7a3043e528486bf8941966037d4e1be9
License Form
Ministry of Health Medical Device Land Transport No. 003505
Customs Code
DHA09600350508
Company information
Manufacturer Country
Taiwan, Province of China;;China
Authorized Representative
MEGASPINE MEDICAL CO., LTD.
Product details
Intended Use
Limited to the first level identification range of manual orthopedic surgical instruments (N.4540) of the Measures for the Administration of Medical Equipment.
Product Type (Level 1)
N Orthopedic devices
Product Type (Level 2)
N4540 Manual osteologic surgery instrument
Import Information
Imported from abroad; Contract manufacturing;; Made in China
Dates and status
Registration Date
Jul 30, 2018
Expiry Date
Jul 30, 2028
About this record

Access comprehensive regulatory information for "Megaspine" MIS instruments for spinal internal fixation (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 7a3043e528486bf8941966037d4e1be9 and manufactured by CHANGZHOU CONDYN MEDICAL INSTRUMENT CO.,LTD;;MEGASPINE MEDICAL CO., LTD.. The authorized representative in Taiwan is MEGASPINE MEDICAL CO., LTD..

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