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"Opron" Clostridium difficile antigen test reagent (unsterilized) - Taiwan Registration 0457984c252e99386c3f2032f88bf5a1

Access comprehensive regulatory information for "Opron" Clostridium difficile antigen test reagent (unsterilized) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 0457984c252e99386c3f2032f88bf5a1 and manufactured by OPERON, S.A.. The authorized representative in Taiwan is GREAT MEDICAL SCIENCE INC..

This page provides complete technical specifications, regulatory compliance details. 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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0457984c252e99386c3f2032f88bf5a1
Registration Details
Taiwan FDA Registration: 0457984c252e99386c3f2032f88bf5a1
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Device Details

"Opron" Clostridium difficile antigen test reagent (unsterilized)
TW: โ€œๆญๆ™ฎ้š†โ€ ๅ›ฐ้›ฃๆขญ็‹€ๆกฟ่ŒๆŠ—ๅŽŸๆชข้ฉ—่ฉฆๅŠ‘(ๆœชๆป…่Œ)
Risk Class 1

Registration Details

0457984c252e99386c3f2032f88bf5a1

DHA09402264706

Company Information

Spain

Product Details

Limited to the first level identification scope of the Measures for the Classification and Grading of Medical Devices "Microbial Identification and Determination Equipment (C.2660)".

C Immunology and microbiology

C.2660 ๅพฎ็”Ÿ็‰ฉ้‘‘ๅˆฅๅŠๆธฌๅฎšๅ™จๆ

Input;; QMS/QSD

Dates and Status

Sep 11, 2021

Sep 11, 2026