Taiwan FDA registration 7291ddc28e19024b864b0358e774f532

“Randox” Immunoassay Premium Plus

TW: “瑞德士” 免疫分析品管液
Taiwan flagTaiwan·Risk Class 2·MD·RANDOX LABORATORIES LTD.·Registered Oct 01, 2018 – Oct 01, 2023Expired
Registration details
Analysis ID
7291ddc28e19024b864b0358e774f532
License Form
Ministry of Health Medical Device Import No. 031485
Customs Code
DHA05603148500
Company information
Manufacturer Country
United Kingdom
Authorized Representative
KUO'S YUAN IN ENTERPRISE CO., LTD.
Product details
Intended Use
It is used in vitro diagnosis as a quality control material for diagnostic clinical biochemistry and immunoassay testing. This product can be used to monitor the accuracy or reproducibility of immunoassay tests.
Product Type (Level 1)
A Clinical chemistry and clinical toxicology
Product Type (Level 2)
A1660 Quality Control Materials (Analytical and Non-Analytical)
Import Information
Imported from abroad
Dates and status
Registration Date
Oct 01, 2018
Expiry Date
Oct 01, 2023
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About this record

Access comprehensive regulatory information for “Randox” Immunoassay Premium Plus in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 2 medical device is registered under number 7291ddc28e19024b864b0358e774f532 and manufactured by RANDOX LABORATORIES LTD.. The authorized representative in Taiwan is KUO'S YUAN IN ENTERPRISE CO., LTD..

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