Taiwan FDA registration 9bb3b47d88e1f60f7bea244381acb9a0
DXN Total Bilirubin Reagent
TW: 德信總膽紅素試劑
Taiwan·Risk Class 2·DIASYS DIAGNOSTIC SYSTEMS GMBH·Registered May 31, 2022 – May 31, 2027ActiveRegistration details
- Analysis ID
- 9bb3b47d88e1f60f7bea244381acb9a0
- Customs Code
- DHA05603565404
Company information
- Manufacturer
- DIASYS DIAGNOSTIC SYSTEMS GMBH
- Manufacturer Country
- Germany
- Authorized Representative
- TUNYEN ENTERPRISE CORPORATION
Product details
- Intended Use
- In vitro diagnostic reagent for the quantitative determination of total 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
- QMS/QSD;; 輸入
Dates and status
- Registration Date
- May 31, 2022
- Expiry Date
- May 31, 2027
About this record
Access comprehensive regulatory information for DXN Total 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 9bb3b47d88e1f60f7bea244381acb9a0 and manufactured by DIASYS DIAGNOSTIC SYSTEMS GMBH. The authorized representative in Taiwan is TUNYEN ENTERPRISE CORPORATION.
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