Taiwan FDA registration 3ccfd389c2db2ea17f8907ae4ad6f00a
“Bittium” Long-term Electrocardiograph Recording and Analyzing System
TW: “必緹恩” 長時程心電圖紀錄與分析系統
Taiwan·Risk Class 2·MD·Bittium Biosignals Ltd.·Registered Mar 23, 2021 – Mar 23, 2026ExpiredRegistration details
- Analysis ID
- 3ccfd389c2db2ea17f8907ae4ad6f00a
- License Form
- Ministry of Health Medical Device Import No. 034470
- Customs Code
- DHA05603447002
Company information
- Manufacturer
- Bittium Biosignals Ltd.
- Manufacturer Country
- Finland
- Authorized Representative
- Onemed Co., Ltd.
Product details
- Intended Use
- For details, it is Chinese approved copy of the imitation order
- Product Type (Level 1)
- E Cardiovascular devices
- Product Type (Level 2)
- E2340 ECG Scanner
- Import Information
- Imported from abroad
Dates and status
- Registration Date
- Mar 23, 2021
- Expiry Date
- Mar 23, 2026
About this record
Access comprehensive regulatory information for “Bittium” Long-term Electrocardiograph Recording and Analyzing System in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 3ccfd389c2db2ea17f8907ae4ad6f00a and manufactured by Bittium Biosignals Ltd.. The authorized representative in Taiwan is Onemed Co., Ltd..
This page provides complete technical specifications, regulatory compliance details. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.
Free DatabasePowered by Pure Global AI89,000+ Devices