240366
C
current
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancerไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ่ฟ็คๆ ๅฟ็ฉ, ไนณ่ บ็
This profile provides complete Hong Kong MDACS registration information for IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancer. 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, Tumor Marker, Breast Cancer
็ขๅ่ณ่จ๏ผ ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ ็ซๆตๅฎ, ่ฟ็คๆ ๅฟ็ฉ, ไนณ่ บ็
Device Overview
Hong Kong MDACS registration summary and classification details.
Risk Class
C
Product Code
37582
Product Code Detail
37582 IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Breast Cancer
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
September 11, 2024
Expiry Date
September 10, 2029
Product Models
Atellica IM HER-2/neu (10995591), Atellica IM HER-2/neu Calibrator (10995592), Atellica IM HER-2/neu Quality Control (10995594)
Atellica IM HER-2/ๆ(10995591)ใAtellica IM HER-2/ๆๆ กๅๅจ(10995592)ใAtellica IM HER-2/ๆ่ดจ้ๆงๅถ(10995594)