Taiwan FDA registration 67c1efea3fdc2bf7d5f3c4195e57a224
"Triangular" surgical headlamp (unsterilized)
TW: “三稜”手術用頭燈(未滅菌)
Registration details
- Analysis ID
- 67c1efea3fdc2bf7d5f3c4195e57a224
Company information
- Manufacturer
- QUEN LIN INSTRUMENTS CO., LTD.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- SAN LENG INTERNATIONAL 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
- Jan 16, 2019
- Expiry Date
- Jan 16, 2024
About this record
Access comprehensive regulatory information for "Triangular" 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 67c1efea3fdc2bf7d5f3c4195e57a224 and manufactured by QUEN LIN INSTRUMENTS CO., LTD.. The authorized representative in Taiwan is SAN LENG INTERNATIONAL CO., LTD..
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