Taiwan FDA registration d61e86e115fa607aab34627b6c89fa7b

"Xinwei" surgical headlamps and their accessories (unsterilized)

TW: "新韋" 外科用頭燈及其配件 (未滅菌)

Taiwan·Risk Class 1·KUANG HSING BIOTECH CO., LTD.·Registered Nov 10, 2016 – Nov 10, 2021Cancelled

Registration details

Analysis ID: d61e86e115fa607aab34627b6c89fa7b

Company information

Manufacturer: KUANG HSING BIOTECH CO., LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: SHINWEI INSTRUMENT INDUSTRY LTD.

Product details

Intended Use: Limited to the first level identification range of the Measures for the Administration of Medical Devices "Surgical Headlamps (M.4335)".
Product Type (Level 1): M Ophthalmology
Product Type (Level 2): M.4335 Headlamps for surgery
Import Information: Contract manufacturing;; Domestic

Dates and status

Registration Date: Nov 10, 2016
Expiry Date: Nov 10, 2021
Cancellation Date: Aug 15, 2023

Cancellation information

Status: Logged out
Reason: 許可證已逾有效期

About this record

Access comprehensive regulatory information for "Xinwei" surgical headlamps and their accessories (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number d61e86e115fa607aab34627b6c89fa7b and manufactured by KUANG HSING BIOTECH CO., LTD.. The authorized representative in Taiwan is SHINWEI INSTRUMENT INDUSTRY LTD..

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