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"Bolhenium" rapid test reagent reader (unsterilized) - Taiwan Registration 3d51b9f9f61af87fc6ea49cdf41ba305

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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3d51b9f9f61af87fc6ea49cdf41ba305
Registration Details
Taiwan FDA Registration: 3d51b9f9f61af87fc6ea49cdf41ba305
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Device Details

"Bolhenium" rapid test reagent reader (unsterilized)
TW: "ๅš้Œธ" ๅฟซ้€Ÿๆชข้ฉ—่ฉฆๅŠ‘ๅˆค่ฎ€ๅ„€(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

3d51b9f9f61af87fc6ea49cdf41ba305

Company Information

Taiwan, Province of China

Product Details

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.

A Clinical chemistry and clinical toxicology

A.2400 Density Meter/Sweeper for Clinical Use (Separation, Reflection, Thin Layer or Radioactive Color Layer Analysis)

ๅง”่จ—่ฃฝ้€ ;; QMS/QSD;; ๅœ‹็”ข

Dates and Status

Jun 08, 2018

Jun 08, 2023