Taiwan FDA registration 29ff37c677db73330b669e18aa4f3f36
"Borrhen" rapid test reagent reader (2nd generation) (unsterilized)
TW: "博錸" 快速檢測試劑判讀儀(第二代) (未滅菌)
Taiwan·Risk Class 1·Borhenium Biotechnology Co., Ltd.;; Wistron Capital Communications Co., Ltd·Registered Mar 21, 2023 – Mar 21, 2028ActiveRegistration details
- Analysis ID
- 29ff37c677db73330b669e18aa4f3f36
Company information
- Manufacturer Country
- Taiwan, Province of China
- Authorized Representative
- PLEXBIO CO., LTD.
Product details
- Intended Use
- Limited to the first level of identification range of "density meter/scanner for clinical use (integration, reflection, thin layer chromolayer or radioactive chromolayer analysis)" (A.2400) of the Measures for the Classification and Grading of Medical Devices.
- Product Type (Level 1)
- A Clinical chemistry and clinical toxicology
- Product Type (Level 2)
- A.2400 Density Meter/Sweeper for Clinical Use (Separation, Reflection, Thin Layer or Radioactive Color Layer Analysis)
- Import Information
- QMS/QSD;; 委託製造;; 國產
Dates and status
- Registration Date
- Mar 21, 2023
- Expiry Date
- Mar 21, 2028
About this record
Access comprehensive regulatory information for "Borrhen" rapid test reagent reader (2nd generation) (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 29ff37c677db73330b669e18aa4f3f36 and manufactured by Borhenium Biotechnology Co., Ltd.;; Wistron Capital Communications Co., Ltd. The authorized representative in Taiwan is PLEXBIO CO., LTD..
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