Taiwan FDA registration a198e1fb8ec724bd1f2620d1f1302815
"Enova" Operating headlamp (Non-sterile)
TW: "宜諾娃" 手術用頭燈 (未滅菌)
Registration details
- Analysis ID
- a198e1fb8ec724bd1f2620d1f1302815
- License Form
- Ministry of Health Medical Device Import No. 016138
- Customs Code
- DHA09401613802
Company information
- Manufacturer
- ENOVA ILLUMINATION, LLC
- Manufacturer Country
- United States
- Authorized Representative
- COSMET CO., 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 Ophthalmic devices
- Product Type (Level 2)
- M4335 Surgical headlamp
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Feb 02, 2016
- Expiry Date
- Feb 02, 2021
About this record
Access comprehensive regulatory information for "Enova" 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 a198e1fb8ec724bd1f2620d1f1302815 and manufactured by ENOVA ILLUMINATION, LLC. The authorized representative in Taiwan is COSMET CO., LTD..
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