Taiwan FDA registration 82673201091f05083c40cb5e5093b933

“J.O.” Gaia Kyphoplasty Kit

TW: “傑奎”蓋亞椎體球囊成型術套組
Taiwan flagTaiwan·Risk Class 2·MD·Jiekui Technology Co., Ltd. Nanke Branch·Registered Oct 06, 2022 – Oct 06, 2027Active
Registration details
Analysis ID
82673201091f05083c40cb5e5093b933
License Form
Ministry of Health Medical Device Manufacturing No. 007539
Company information
Manufacturer Country
Taiwan, Province of China
Product details
Intended Use
Details are as detailed as approved Chinese instructions
Product Type (Level 1)
N Orthopedics
Product Type (Level 2)
N0004 Bone Dilation Molding System
Import Information
Produced in Taiwan, China
Dates and status
Registration Date
Oct 06, 2022
Expiry Date
Oct 06, 2027
About this record

Access comprehensive regulatory information for “J.O.” Gaia Kyphoplasty Kit in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 82673201091f05083c40cb5e5093b933 and manufactured by Jiekui Technology Co., Ltd. Nanke Branch. The authorized representative in Taiwan is Jiekui Technology Co., Ltd. Nanke Branch.

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