5 Devices
BioMerieux S.A. - Applicant Profile
Biomรฉrieux
BioMerieux S.A. is associated with 5 medical devices registered under the Hong Kong Medical Device Administrative Control System (MDACS). Explore bilingual product names, risk classes, authorised representatives, and life-cycle milestones.
3 Risk Classes
Since 2022
Latest 2023
Applicant Overview
Bilingual manufacturer details sourced from Hong Kong MDACS.
Applicant (EN)
BioMerieux S.A.
Applicant (ZH)
Biomรฉrieux
Address
376, Chemin de I'Orme, 69280 MARCY L ETOILE FRANCE
376, Chemin de I'Orme, 69280 MARCY L ETOILE ่้ฆๅ
ฌๆฅ ANCE
Recent MDACS Registrations
Latest 15 devices linked to this applicant.
| Device | Risk Class | Authorised Rep | Registered |
|---|---|---|---|
| IVD Test Reagent/Kits, Serology, Virus, Cytomegalovirus, IgG Antibody ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ
ๅญฆใ็
ๆฏใๅทจ็ป่็
ๆฏใIgG ๆไฝ | C | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | Sep 12, 2023 |
| IVD Test Reagent/Kits, Serology, Virus, Rubella, IgG Antibody ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ
ๅญฆใ็
ๆฏใ้ฃ็นใIgG ๆไฝ | C | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | Apr 06, 2023 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใ้้็ด ๅ | C | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | Oct 18, 2022 |
| IVD Test Reagent/Kits, Immunoassay, Vitamin, D Metabolite, 25-Hydroxyvitamin D ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ็ปด็็ด ใD ไปฃ่ฐข็ฉใ25-็พๅบ็ปด็็ด D | B | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | Aug 31, 2022 |
| IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใ่กๆธ
ๅญฆใ็
ๆฏใไนๅ่็ใ่กจ้ขๆๅ | D | BioMerieux China Ltd. ็็ฉๆข
้ๅไธญๅฝๆ้ๅ
ฌๅธ | Aug 31, 2022 |
Risk Class Breakdown
B1
C3
D1
Timeline
First Registration
Aug 31, 2022
Most Recent
Sep 12, 2023