Pure Global
241043
B
current

IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Ironไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ไธดๅบŠๅŒ–ๅญฆใ€็—•้‡้‡‘ๅฑžใ€้“

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Iron. 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, Clinical Chemistry, Trace Metal, Iron

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ไธดๅบŠๅŒ–ๅญฆใ€็—•้‡้‡‘ๅฑžใ€้“

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
18923
Product Code Detail
18923 IVD Test Reagent/Kits, Clinical Chemistry, Trace Metal, Iron
State
current
Status
N/A
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Manufacturer (่ฃฝ้€ ๅ•†)
Siemens Healthcare Diagnostics Inc
Siemens Healthcare Diagnostics Inc
United States
็พŽๅ›ฝ
511 Benedict Avenue, Tarrytown, NewYork 10591, USA
511 Benedict Avenue, Tarrytown, New York 10591, USA
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้—จๅญๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
25833388
Regulatory Timeline
Registration Date
September 24, 2024
Expiry Date
September 23, 2029
Product Models
Atellica CH Iron3 (Iron3) (11537211)
Atellica CH Iron3 (้“3) (11537211)