Taiwan FDA registration 8fd50af071935926241b3dce16549f8b
"bti" Operating Headlamp (Non-Sterile)
TW: "明華"手術用頭燈(未滅菌)
Registration details
- Analysis ID
- 8fd50af071935926241b3dce16549f8b
- License Form
- Ministry of Health Medical Device Import No. 019465
- Customs Code
- DHA09401946503
Company information
- Manufacturer
- HOGIES AUSTRALIA PTY LTD
- Manufacturer Country
- Australia
- Authorized Representative
- BIOEVOLVE TECHNOLOGY INC.
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 Ophthalmic devices
- Product Type (Level 2)
- M4335 Surgical headlamp
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Aug 08, 2018
- Expiry Date
- Aug 08, 2023
About this record
Access comprehensive regulatory information for "bti" Operating Headlamp (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 8fd50af071935926241b3dce16549f8b and manufactured by HOGIES AUSTRALIA PTY LTD. The authorized representative in Taiwan is BIOEVOLVE TECHNOLOGY INC..
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