Taiwan FDA registration a7b17cb200a4742fd196a4a36bc943ca

"Bolhenium" fluorescence analyzer (unsterilized)

TW: “博錸” 螢光分析儀 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·Borhenium Biotechnology Co., Ltd.;; Wistron Capital Communications Co., Ltd·Registered Oct 01, 2021 – Oct 31, 2025Expired
Registration details
Analysis ID
a7b17cb200a4742fd196a4a36bc943ca
Company information
Manufacturer Country
Taiwan, Province of China
Authorized Representative
PLEXBIO CO., LTD.
Product details
Intended Use
Limited to the classification and grading management measures of medical equipment "fluorescence instrument for clinical use (A.2560)" the first level identification range.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A.2560 Fluorometer for clinical use
Import Information
國產;; 委託製造;; QMS/QSD
Dates and status
Registration Date
Oct 01, 2021
Expiry Date
Oct 31, 2025
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About this record

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 a7b17cb200a4742fd196a4a36bc943ca and manufactured by Borhenium Biotechnology Co., Ltd.;; Wistron Capital Communications Co., Ltd. The authorized representative in Taiwan is PLEXBIO CO., LTD..

This page provides complete technical specifications, regulatory compliance details, 1 companies making similar products including WISTRON CORPORATION, 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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