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"Borrhen" rapid test reagent reader (2nd generation) (unsterilized) - Taiwan Registration 29ff37c677db73330b669e18aa4f3f36

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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29ff37c677db73330b669e18aa4f3f36
Registration Details
Taiwan FDA Registration: 29ff37c677db73330b669e18aa4f3f36
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Device Details

"Borrhen" rapid test reagent reader (2nd generation) (unsterilized)
TW: "ๅš้Œธ" ๅฟซ้€Ÿๆชขๆธฌ่ฉฆๅŠ‘ๅˆค่ฎ€ๅ„€(็ฌฌไบŒไปฃ) (ๆœชๆป…่Œ)
Risk Class 1

Registration Details

29ff37c677db73330b669e18aa4f3f36

Company Information

Product Details

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.

A Clinical chemistry and clinical toxicology

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

QMS/QSD;; ๅง”่จ—่ฃฝ้€ ;; ๅœ‹็”ข

Dates and Status

Mar 21, 2023

Mar 21, 2028