Taiwan FDA registration b9a8624c0a7b323a517ea20f05c23296

"SHINWEI" HEAD LIGHTS (Non-sterile)

TW: "新韋儀器" 外科用頭燈及其配件(未滅菌)

Taiwan·Risk Class 1·MD·SHINWEI INSTRUMENT INDUSTRY LTD.·Registered May 10, 2022 – May 10, 2027Active

Registration details

Analysis ID: b9a8624c0a7b323a517ea20f05c23296
License Form: Ministry of Health Medical Device Manufacturing No. 009559

Company information

Manufacturer: SHINWEI INSTRUMENT INDUSTRY LTD.
Manufacturer Country: Taiwan, Province of China
Authorized Representative: SHINWEI INSTRUMENT INDUSTRY 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): M4335 Surgical headlamp
Import Information: Produced in Taiwan, China

Dates and status

Registration Date: May 10, 2022
Expiry Date: May 10, 2027

About this record

Access comprehensive regulatory information for "SHINWEI" HEAD LIGHTS (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number b9a8624c0a7b323a517ea20f05c23296 and manufactured by SHINWEI INSTRUMENT INDUSTRY LTD.. The authorized representative in Taiwan is SHINWEI INSTRUMENT INDUSTRY LTD..

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.