Taiwan FDA registration 8f328071d8b184bc03e49d4c86942d09

"Hibergene" Mycoplasma Pneumoniae Test (Non-sterile)

TW: "艾柏基因" 肺炎黴漿菌檢測試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·HIBERGENE DIAGNOSTICS LTD.·Registered Oct 27, 2017 – Oct 27, 2022Expired
Registration details
Analysis ID
8f328071d8b184bc03e49d4c86942d09
License Form
Ministry of Health Medical Device Import No. 018455
Customs Code
DHA09401845508
Company information
Manufacturer Country
Ireland
Authorized Representative
YOULUM BIOTECHNOLOGY CO., LTD.
Product details
Intended Use
Limited to the first level identification range of the Measures for the Administration of Medical Devices "Mycoplasma Serological Reagent (C.3375)".
Product Type (Level 1)
C Immunology and microbiology devices
Product Type (Level 2)
C3375 Mycoplasma serum reagent
Import Information
Imported from abroad
Dates and status
Registration Date
Oct 27, 2017
Expiry Date
Oct 27, 2022
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About this record

Access comprehensive regulatory information for "Hibergene" Mycoplasma Pneumoniae Test (Non-sterile) in Taiwan's medical device market through Pure Global AI's free database. This Risk Class 1 medical device is registered under number 8f328071d8b184bc03e49d4c86942d09 and manufactured by HIBERGENE DIAGNOSTICS LTD.. The authorized representative in Taiwan is YOULUM BIOTECHNOLOGY CO., LTD..

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