Pure Global
240127
B
current

IVD Test Reagent/Kits, Immunoassay, Anemia Test, Ferritinไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่ดซ่ก€ๆต‹่ฏ•ใ€้“่›‹็™ฝ

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Anemia Test, Ferritin. 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, Immunoassay, Anemia Test, Ferritin

็”ขๅ“่ณ‡่จŠ๏ผš ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่ดซ่ก€ๆต‹่ฏ•ใ€้“่›‹็™ฝ

Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
17342
Product Code Detail
17342 IVD Test Reagent/Kits, Immunoassay, Anemia Test, Ferritin
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 Ave, Tarrytown NY 10591, USA
511ๆœฌๅฐผ่ฟชๅ…‹็‰นๅคง้“,็บฝ็บฆๅก”้‡Œๆ•ฆ10591,็พŽๅ›ฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้—จๅญๅŒป็–—ๆœ‰้™ๅ…ฌๅธ
25833388
Regulatory Timeline
Registration Date
April 18, 2024
Expiry Date
April 17, 2029
Product Models
Atellica IM Ferritin (Fer) (10995568, 10995569), Atellica IM Calibrator C (CAL C) (10995506, 10995507)
Atellica IM ้“่›‹็™ฝ (Fer) (10995568, 10995569), Atellica IM ๆ กๅ‡†ๅ™จ C (CAL C) (10995506, 10995507)