Taiwan FDA registration 2f0d22dfc51cf332c92fff1a504e72b0

"Hibergene" Mycoplasma Pneumoniae Test (Non-sterile)

TW: "艾柏基因" 肺炎黴漿菌核酸檢測試劑 (未滅菌)
Taiwan flagTaiwan·Risk Class 1·MD·HIBERGENE DIAGNOSTICS·Registered Jul 05, 2022 – Jul 05, 2027Active
Registration details
Analysis ID
2f0d22dfc51cf332c92fff1a504e72b0
License Form
Ministry of Health Medical Device Import No. 022846
Customs Code
DHA09402284602
Company information
Manufacturer Country
Ireland
Authorized Representative
YOULUM BIOTECHNOLOGY CO., LTD.
Product details
Intended Use
Limited to the classification and grading management method of medical equipment, the first level identification range of "Mycoplasma serum reagent (C.3375)".
Product Type (Level 1)
C Immunology and microbiology
Product Type (Level 2)
C3375 Mycoplasma serum reagent
Import Information
Imported from abroad; GMP
Dates and status
Registration Date
Jul 05, 2022
Expiry Date
Jul 05, 2027
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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 2f0d22dfc51cf332c92fff1a504e72b0 and manufactured by HIBERGENE DIAGNOSTICS. 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 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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