Taiwan FDA registration 204f7700a6e01ba04df004a6a5c2fa02
DXN Direct Bilirubin Reagent
TW: 德信直接膽紅素試劑
Taiwan·Risk Class 2·DIASYS DIAGNOSTIC SYSTEMS GMBH·Registered Dec 30, 2021 – Dec 30, 2026ActiveRegistration details
- Analysis ID
- 204f7700a6e01ba04df004a6a5c2fa02
- Customs Code
- DHA05603492800
Company information
- Manufacturer
- DIASYS DIAGNOSTIC SYSTEMS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- TUNYEN ENTERPRISE CORPORATION
Product details
- Intended Use
- In vitro diagnostic reagents for the quantitative determination of direct bilirubin in serum or plasma on a photometric system.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.1110 Bilirubin (total or direct) test system
- Import Information
- Input;; QMS/QSD
Dates and status
- Registration Date
- Dec 30, 2021
- Expiry Date
- Dec 30, 2026
About this record
Access comprehensive regulatory information for DXN Direct Bilirubin Reagent in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 204f7700a6e01ba04df004a6a5c2fa02 and manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH. The authorized representative in Taiwan is TUNYEN ENTERPRISE CORPORATION.
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