Taiwan FDA registration 3fa5f7341110350fc9becf1eaf85df8a

"Fisper" surgical headlamp (unsterilized)

TW: "菲思博" 手術用頭燈 (未滅菌)

Taiwan·Risk Class 1·Rongkang Technology Co., Ltd. (Plant 4)·Registered May 13, 2020 – May 13, 2025Expired

Registration details

Analysis ID: 3fa5f7341110350fc9becf1eaf85df8a

Company information

Manufacturer: Rongkang Technology Co., Ltd. (Plant 4)
Manufacturer Country: Taiwan, Province of China
Authorized Representative: FASPRO SYSTEMS CO., LTD.

Product details

Intended Use: Limited to the classification and grading management measures of medical equipment "Surgical Headlamp (M.4335)" first level identification range.
Product Type (Level 1): M Ophthalmology
Product Type (Level 2): M.4335 Headlamps for surgery
Import Information: Domestic;; Contract manufacturing

Dates and status

Registration Date: May 13, 2020
Expiry Date: May 13, 2025

About this record

Access comprehensive regulatory information for "Fisper" surgical headlamp (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3fa5f7341110350fc9becf1eaf85df8a and manufactured by Rongkang Technology Co., Ltd. (Plant 4). The authorized representative in Taiwan is FASPRO SYSTEMS CO., LTD..

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