Taiwan FDA registration 36dc776bba8cc6c6c0f52673cd483b8e
“M. I. ONE” Ear, nose and throat examination and treatment unit (Non-Sterile)
TW: "恩艾萬"耳鼻喉檢查及治療檯 (未滅菌)
Registration details
- Analysis ID
- 36dc776bba8cc6c6c0f52673cd483b8e
- License Form
- Ministry of Health Medical Device Import No. 021023
- Customs Code
- DHA09402102302
Company information
- Manufacturer
- M.I.ONE CO., LTD
- Manufacturer Country
- Korea, Republic of
- Authorized Representative
- WHOLE WELL CO., LTD.
Product details
- Intended Use
- Limited to the first level of identification scope of the Measures for the Administration of Medical Devices "ENT Examination and Treatment Unit (G.5300)".
- Product Type (Level 1)
- G ENT device
- Product Type (Level 2)
- G5300 ENT Examination and Treatment Unit
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Nov 19, 2019
- Expiry Date
- Nov 19, 2024
About this record
Access comprehensive regulatory information for “M. I. ONE” Ear, nose and throat examination and treatment unit (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 36dc776bba8cc6c6c0f52673cd483b8e and manufactured by M.I.ONE CO., LTD. The authorized representative in Taiwan is WHOLE WELL CO., LTD..
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