Taiwan FDA registration a12befda967411efe1ffd70de9b43a5f
“Digisine” Otoscope (Non-Sterile)
TW: “元皓”耳鏡(未滅菌)
Taiwan·Risk Class 1·MD·Yuanhao Energy Co., Ltd. Linguang Processing Zone Plant·Registered Sep 03, 2021 – Sep 03, 2026ActiveRegistration details
- Analysis ID
- a12befda967411efe1ffd70de9b43a5f
- License Form
- Ministry of Health Medical Device Manufacturing No. 009288
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- Yuanhao Energy Co., Ltd. Linguang Processing Zone Plant
Product details
- Intended Use
- Limited to the first level identification range of the "Otoscope (G.4770)" of the Administrative Measures for the Classification and Grading of Medical Equipment.
- Product Type (Level 1)
- G ENT device
- Product Type (Level 2)
- G4770 Otoscope
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Sep 03, 2021
- Expiry Date
- Sep 03, 2026
About this record
Access comprehensive regulatory information for “Digisine” Otoscope (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 a12befda967411efe1ffd70de9b43a5f and manufactured by Yuanhao Energy Co., Ltd. Linguang Processing Zone Plant. The authorized representative in Taiwan is Yuanhao Energy Co., Ltd. Linguang Processing Zone Plant.
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