Pure Global
240035
B
current

IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Binding Ratioไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’,ๅ…็–ซๆต‹ๅฎš,็”ฒ็Šถ่…บๆฟ€็ด ,็ป“ๅˆๆฏ”

This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Binding Ratio. 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, Thyroid Hormone, Binding Ratio

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Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
B
Product Code
19864
Product Code Detail
19864 IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Binding Ratio
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
February 06, 2024
Expiry Date
February 06, 2029
Product Models
Atellica IM Thyroid Uptake (TUp) (10995711, 10995712)
Atellica IM ็”ฒ็Šถ่…บๆ‘„ๅ– (TUp) (10995711, 10995712)