Taiwan FDA registration ef325e3c64e4617ab272a830b4382bd3
“Bittium” BrainStatus EEG System
TW: “必緹恩”腦波系統
Taiwan·Risk Class 2·MD·Bittium Biosignals Ltd.·Registered Jul 19, 2023 – Jul 19, 2028ActiveRegistration details
- Analysis ID
- ef325e3c64e4617ab272a830b4382bd3
- License Form
- Ministry of Health Medical Device Import No. 036674
- Customs Code
- DHA05603667402
Company information
- Manufacturer
- Bittium Biosignals Ltd.
- Manufacturer Country
- Finland
- Authorized Representative
- Onemed Co., Ltd.
Product details
- Intended Use
- Details are as detailed as approved Chinese instructions
- Product Type (Level 1)
- K Neuroscience
- Product Type (Level 2)
- K1400 brainwave scanner
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Jul 19, 2023
- Expiry Date
- Jul 19, 2028
About this record
Access comprehensive regulatory information for “Bittium” BrainStatus EEG System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number ef325e3c64e4617ab272a830b4382bd3 and manufactured by Bittium Biosignals Ltd.. The authorized representative in Taiwan is Onemed Co., Ltd..
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