Taiwan FDA registration 8dbaf0f88856b0e8441bd66c2a2cb511

"Rongsheng" non-powered neurosurgical instruments (unsterilized)

TW: "榮晟" 非動力式神經外科用器械 (未滅菌)

Taiwan·Risk Class 1·A-SPINE Asia Co., Ltd.·Registered Jan 15, 2016 – Jan 15, 2021Cancelled

Registration details

Analysis ID: 8dbaf0f88856b0e8441bd66c2a2cb511

Company information

Manufacturer: A-SPINE Asia Co., Ltd.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: MARKSTEIN SICHTEC MEDICAL CORPORATION

Product details

Intended Use: Limited to the first level identification scope of the Measures for the Administration of Medical Devices "Non-powered Neurosurgical Devices (K.4535)".
Product Type (Level 1): K Neuroscience
Product Type (Level 2): K.4535 非動力式神經外科用器械
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: Jan 15, 2016
Expiry Date: Jan 15, 2021
Cancellation Date: Sep 08, 2023

Cancellation information

Status: Logged out
Reason: 未展延而逾期者

About this record

Access comprehensive regulatory information for "Rongsheng" non-powered neurosurgical instruments (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8dbaf0f88856b0e8441bd66c2a2cb511 and manufactured by A-SPINE Asia Co., Ltd.. The authorized representative in Taiwan is MARKSTEIN SICHTEC MEDICAL CORPORATION.

This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.