Taiwan FDA registration cf11436d83fd6518d2d9f25bd351d08f
"Yilite" high-resolution microscopic ultrasound system for medical agents
TW: “醫利特” 醫特務高解析度顯微超音波系統
Taiwan·Risk Class 2·Sonele Inc.;; Exact Imaging Inc.·Registered Sep 01, 2024 – Sep 01, 2029ActiveRegistration details
- Analysis ID
- cf11436d83fd6518d2d9f25bd351d08f
- Customs Code
- DHA05603740101
Company information
- Manufacturer
- Sonele Inc.;; Exact Imaging Inc.
- Manufacturer Country
- Canada
- Authorized Representative
- JIANHE BIO-MEDICAL LTD.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- P Radiology Science
- Product Type (Level 2)
- P.1550 Ultrasonic pulsating Duppler imaging system
- Import Information
- Contract manufacturing;; input
Dates and status
- Registration Date
- Sep 01, 2024
- Expiry Date
- Sep 01, 2029
About this record
Access comprehensive regulatory information for "Yilite" high-resolution microscopic ultrasound system for medical agents in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number cf11436d83fd6518d2d9f25bd351d08f and manufactured by Sonele Inc.;; Exact Imaging Inc.. The authorized representative in Taiwan is JIANHE BIO-MEDICAL LTD..
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