240039
C
current
IVD Test Reagent/Kits, Clinical Chemistry, Amino Acid, Homocysteine, Totalไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็, ไธดๅบๅๅญฆ, ๆฐจๅบ้ ธ, ๅๅๅ่ฑๆฐจ้ ธ, ๆป่ฎก
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Clinical Chemistry, Amino Acid, Homocysteine, Total. 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, Amino Acid, Homocysteine, Total
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็, ไธดๅบๅๅญฆ, ๆฐจๅบ้ ธ, ๅๅๅ่ฑๆฐจ้ ธ, ๆป่ฎก
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
28034
Product Code Detail
28034 IVD Test Reagent/Kits, Clinical Chemistry, Amino Acid, Homocysteine, Total
State
current
Status
N/A
Manufacturer (่ฃฝ้ ๅ)
Siemens Healthcare Diagnostics Inc.
Siemens Healthcare Diagnostics Inc
United States
็พๅฝ
511 Benedict Ave, Tarrytown NY 10591, USA
511ๆฌๅฐผ่ฟชๅ
็นๅคง้,็บฝ็บฆๅก้ๆฆ10591,็พๅฝ
Authorised Representative (AR)
Siemens Healthcare Limited
่ฅฟ้จๅญๅป็ๆ้ๅ
ฌๅธ
25833388
Regulatory Timeline
Registration Date
February 06, 2024
Expiry Date
February 06, 2029
Product Models
Atellica IM Homocysteine (HCY) (10995606, 10995607), Atellica IM Homocysteine Calibrator (HCY CAL) (10995498), Atellica IM Homocysteine Diluent (HCY DIL) (10995608)
Atellica IM ๅๅๅ่ฑๆฐจ้
ธ (HCY) (10995606, 10995607)ใAtellica IM ๅๅๅ่ฑๆฐจ้
ธๆ กๅๅ (HCY CAL) (10995498)ใAtellica IM ๅๅๅ่ฑๆฐจ้
ธ็จ้ๅ (HCY DIL) (10995608)