Pure Global
210392
C
current

IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Anaerobeไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅพฎ็”Ÿ็‰ฉๅญฆใ€็ป†่Œใ€้‰ดๅฎšใ€ๅŽŒๆฐง่Œ

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Anaerobe. Review device classification, authorised representative (AR) details, manufacturer contacts, product codes, and regulatory milestones. Pure Global AI delivers bilingual transparency for medical device registrations across Asia.

Product Info: IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Anaerobe

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
17261
Product Code Detail
17261 IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Anaerobe
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
bioMerieux, Inc.
Biomรฉrieux
United States
็พŽๅ›ฝ
100 Rodolphe Street, Durham, North Carolina 27712, United States
100 Rodolphe Street, ่พพๅ‹’ๅง†, ๅŒ—ๅก็ฝ—ๆฅ็บณๅทž 27712, ็พŽ
Authorised Representative (AR)
BioMerieux China Ltd.
็”Ÿ็‰ฉๆข…้‡ŒๅŸƒไธญๅ›ฝๆœ‰้™ๅ…ฌๅธ
23567033
Regulatory Timeline
Registration Date
December 03, 2021
Expiry Date
December 03, 2026
Product Models
Vitek 2 ANC Test Card
็ปดๆณฐๅ…‹ 2 ไธปๅŠจ้™ๅ™ชๆต‹่ฏ•ๅก