Taiwan FDA registration 7353042017127f927ac671f5b40259e1
“aetherAI” Computer-aided Polyp Detection (CADe) Systems for Colonoscopy
TW: “雲象”內視鏡大腸瘜肉人工智慧輔助偵測系統
Taiwan·Risk Class 2·MD·aetherAI Co., Ltd.·Registered Jul 11, 2022 – Jul 11, 2027ActiveRegistration details
- Analysis ID
- 7353042017127f927ac671f5b40259e1
- License Form
- Ministry of Health Medical Device Manufacturing No. 007508
Company information
- Manufacturer
- aetherAI Co., Ltd.
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- aetherAI Co., Ltd.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- H Gastroenterology and urology
- Product Type (Level 2)
- H9999 Other
- Import Information
- Produced in Taiwan, China
Dates and status
- Registration Date
- Jul 11, 2022
- Expiry Date
- Jul 11, 2027
About this record
Access comprehensive regulatory information for “aetherAI” Computer-aided Polyp Detection (CADe) Systems for Colonoscopy in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7353042017127f927ac671f5b40259e1 and manufactured by aetherAI Co., Ltd.. The authorized representative in Taiwan is aetherAI Co., Ltd..
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