Taiwan FDA registration 3d51b9f9f61af87fc6ea49cdf41ba305
"Bolhenium" rapid test reagent reader (unsterilized)
TW: "博錸" 快速檢驗試劑判讀儀(未滅菌)
Taiwan·Risk Class 1·WISTRON CORPORATION·Registered Jun 08, 2018 – Jun 08, 2023ExpiredRegistration details
- Analysis ID
- 3d51b9f9f61af87fc6ea49cdf41ba305
Company information
- Manufacturer
- WISTRON CORPORATION
- 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 or radioactive color layer analysis)" (A.2400) under the Measures for the Administration 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
- 委託製造;; QMS/QSD;; 國產
Dates and status
- Registration Date
- Jun 08, 2018
- Expiry Date
- Jun 08, 2023
About this record
Access comprehensive regulatory information for "Bolhenium" rapid test reagent reader (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 3d51b9f9f61af87fc6ea49cdf41ba305 and manufactured by WISTRON CORPORATION. The authorized representative in Taiwan is PLEXBIO CO., LTD..
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