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"Bolhenium" fluorescence analyzer (unsterilized) - Taiwan Registration 14ab3c964be26c3fc07263e60e5a9830

Access comprehensive regulatory information for "Bolhenium" fluorescence analyzer (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 14ab3c964be26c3fc07263e60e5a9830 and manufactured by WISTRON CORPORATION. The authorized representative in Taiwan is PLEXBIO CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including Borhenium Biotechnology Co., Ltd.;; Wistron Capital Communications Co., Ltd, and 1 recent registrations in the same category. Pure Global AI offers free access to 89,000+ Taiwan medical device registrations, helping global MedTech companies navigate Taiwan FDA regulations, identify competitors, and discover partnership opportunities efficiently.

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14ab3c964be26c3fc07263e60e5a9830
Registration Details
Taiwan FDA Registration: 14ab3c964be26c3fc07263e60e5a9830
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Device Details

"Bolhenium" fluorescence analyzer (unsterilized)
TW: โ€œๅš้Œธโ€ ่žขๅ…‰ๅˆ†ๆžๅ„€ (ๆœชๆป…่Œ)
Risk Class 1
Cancelled

Registration Details

14ab3c964be26c3fc07263e60e5a9830

Company Information

Taiwan, Province of China

Product Details

Limited to the first-level identification range of the Measures for the Administration of Medical Devices "Fluorescence Instrument for Clinical Use (A.2560)".

A Clinical chemistry and clinical toxicology

A.2560 Fluorometer for clinical use

ๅœ‹็”ข;; QMS/QSD;; ๅง”่จ—่ฃฝ้€ 

Dates and Status

Feb 21, 2017

Feb 21, 2022

Sep 30, 2021

Cancellation Information

Logged out

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