29 Devices
BioMerieux China Ltd. - Authorised Representative (AR)
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BioMerieux China Ltd. serves as the authorised representative for 29 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.
9 Applicants
Since 2009
Latest 2023
AR Overview
Bilingual authorised representative information and contact details.
Authorised Representative (EN)
BioMerieux China Ltd.
23567033
Authorised Representative (ZH)
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Recent Registrations
Latest 15 MDACS listings represented by BioMerieux China Ltd..
| Device | Risk Class | Applicant | Registered |
|---|---|---|---|
| IVD Test Reagent/Kits, Serology, Virus, Cytomegalovirus, IgG Antibody ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ
ๅญฆใ็
ๆฏใๅทจ็ป่็
ๆฏใIgG ๆไฝ | C | BioMerieux S.A. Biomรฉrieux | Sep 12, 2023 |
| IVD Test Reagent/Kits, Serology, Virus, Rubella, IgG Antibody ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ
ๅญฆใ็
ๆฏใ้ฃ็นใIgG ๆไฝ | C | BioMerieux S.A. Biomรฉrieux | Apr 06, 2023 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใ้้็ด ๅ | C | BioMerieux S.A. Biomรฉrieux | Oct 18, 2022 |
| IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ็ปด็็ด ใD ไปฃ่ฐข็ฉใ25-็พๅบ็ปด็็ด D | B | BioMerieux S.A. Biomรฉrieux | Aug 31, 2022 |
| IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ
ๅญฆใ็
ๆฏใไนๅ่็ใ่กจ้ขๆๅ | D | BioMerieux S.A. Biomรฉrieux | Aug 31, 2022 |
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioFire Diagnostics, LLC Biofire Diagnostics, Llc | May 16, 2022 |
| IVD Test Reagent/Kits, Serology, Virus, Measles, IgG Antibody ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ
ๅญฆใ็
ๆฏใ้บป็นใIgG ๆไฝ | C | BioMerieux S.A Biomรฉrieux | Jan 20, 2022 |
| IVD Test Reagent/Kits, Microbiology, Bacteria, Identification ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅพฎ็็ฉๅญฆใ็ป่ใ้ดๅฎ | C | bioMerieux, Inc. Biomรฉrieux | Dec 03, 2021 |
| IVD Test Reagent/Kits, Microbiology, Bacteria, Identification, Anaerobe ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅพฎ็็ฉๅญฆใ็ป่ใ้ดๅฎใๅๆฐง่ | C | bioMerieux, Inc. Biomรฉrieux | Dec 03, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioFire Diagnostics, LLC Biofire Diagnostics, Llc | Sep 28, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioFire Diagnostics, LLC Biofire Diagnostics, Llc | May 26, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioFire Diagnostics, LLC Biofire Diagnostics, Llc | Apr 09, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection, Bacteria, Staphylococcus aureus, DNA, Antimicrobial-Resistant ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆตๅฎใๆๆใ็ป่ใ้้ป่ฒ่ก่็่ใDNAใๆ่่่ฏๆง | C | BioFire Diagnostics, LLC Biofire Diagnostics, Llc | Apr 09, 2021 |
| IVD Test Reagent/Kits, Molecular Assay, Infection ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅๅญๆฃๆตใๆๆ | C | BioFire Diagnostics, LLC Biofire Diagnostics, Llc | Apr 09, 2021 |
| IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ
ๅญฆใ็
ๆฏใไธๅ่็ใๆไฝ | D | BIOMERIEUX S.A. Biomรฉrieux | Mar 28, 2013 |
Risk Class Distribution
B1
C12
D14
II2
Applicant Partnerships
Top manufacturers represented by this AR.
bioMerieux SA10
BioFire Diagnostics, LLC6
BioMerieux S.A.5
bioMerieux S.A.2
bioMerieux, Inc.2
BIOMERIEUX S.A.1
BioMerieux S.A1
Copan Group1
Copan Italia S.p.A.1
Timeline
First Representation
Mar 20, 2009
Most Recent
Sep 12, 2023