Taiwan FDA registration b09e001fead017a3548896777735dc20

"Ruiti" second-generation spine surgery navigation system

TW: “瑞鈦”二代脊椎手術導航系統

Taiwan·Risk Class 2·The head office of Irons Technology Co., Ltd.;; Ruijin Medical Equipment Co., Ltd·Registered Sep 20, 2024 – Sep 20, 2029Active

Registration details

Analysis ID: b09e001fead017a3548896777735dc20

Company information

Manufacturer: The head office of Irons Technology Co., Ltd.;; Ruijin Medical Equipment Co., Ltd
Manufacturer Country: Taiwan, Province of China
Authorized Representative: Remex Medical Corp.

Product details

Intended Use: Details are as detailed as approved Chinese instructions
Product Type (Level 1): K Neuroscience
Product Type (Level 2): K.4560 Instruments for stereotaxic use of the nervous system
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Sep 20, 2024
Expiry Date: Sep 20, 2029

About this record

Access comprehensive regulatory information for "Ruiti" second-generation spine surgery navigation system in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number b09e001fead017a3548896777735dc20 and manufactured by The head office of Irons Technology Co., Ltd.;; Ruijin Medical Equipment Co., Ltd. The authorized representative in Taiwan is Remex Medical Corp..

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