35 Devices
Beckman Coulter Hong Kong Limited - Authorised Representative (AR)
่ดๅ ๆผๅบๅฐ็น้ฆๆธฏๆ้ๅ ฌๅธ
Beckman Coulter Hong Kong Limited serves as the authorised representative for 35 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.
3 Applicants
Since 2020
Latest 2024
AR Overview
Bilingual authorised representative information and contact details.
Authorised Representative (EN)
Beckman Coulter Hong Kong Limited
28147431
Authorised Representative (ZH)
่ดๅ
ๆผๅบๅฐ็น้ฆๆธฏๆ้ๅ
ฌๅธ
Recent Registrations
Latest 15 MDACS listings represented by Beckman Coulter Hong Kong Limited.
| Device | Risk Class | Applicant | Registered |
|---|---|---|---|
| IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin, Beta ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ
็ซๆตๅฎ, ๅฆๅจ ๆฟ็ด , ไบบ็ปๆฏ่ไฟๆง่
บๆฟ็ด , ฮฒ | C | Beckman Coulter, Inc. Beckman Coulter, Inc. | Sep 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Prolactin ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ็่ฒๆฟ็ด ใๅฌไนณ็ด | C | Beckman Coulter, Inc. Beckman Coulter, Inc. | Sep 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroglobulin ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ็ฒ็ถ่
บๆฟ็ด ใ็ฒ็ถ่
บ็่็ฝ | C | Beckman Coulter, Inc. Beckman Coulter, Inc. | Sep 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ็่ฒๆฟ็ด ใไฟๅตๆณกๆฟ็ด | B | Beckman Coulter, Inc. Beckman Coulter, Inc. | Sep 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Luteinizing Hormone ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็,ๅ
็ซๆตๅฎ,็่ฒๆฟ็ด ,้ปไฝ็ๆ็ด | B | Beckman Coulter, Inc. Beckman Coulter, Inc. | Sep 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ็ฒ็ถ่
บๆฟ็ด ใไฟ็ฒ็ถ่
บ็ด | B | Immunotech SAS, A Beckman Coulter Company Beckman Coulter, Inc. | Sep 20, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Carbohydrate Antigen CA 125 ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่ฟ็คๆ ๅฟ็ฉใ็ขณๆฐดๅๅ็ฉๆๅ CA 125 | C | Beckman Coulter, Inc. Beckman Coulter, Inc. | Aug 08, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyroxin, Free ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็,ๅ
็ซๆตๅฎ,็ฒ็ถ่
บๆฟ็ด ,็ฒ็ถ่
บ็ด ,ๆธธ็ฆป | B | Beckman Coulter, Inc. Beckman Coulter, Inc. | Aug 08, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Myoglobin ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใๅฟ่ๆ ๅฟ็ฉใ่็ฝ่ดจใ่็บข่็ฝ | B | Beckman Coulter, Inc. Beckman Coulter, Inc. | Aug 08, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่ฟ็คๆ ๅฟ็ฉใ้
ถใๅๅ่
บ็นๅผๆงๆๅ | C | Beckman Coulter, Inc. Beckman Coulter, Inc. | Aug 08, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Autoimmune, Thyroid, Peroxidase Antibody ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ
็ซๅๆใ่ช่บซๅ
็ซใ็ฒ็ถ่
บใ่ฟๆฐงๅ็ฉ้
ถๆไฝ | B | Beckman Coulter, Inc. Beckman Coulter, Inc. | Aug 08, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Procalcitonin ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใ้้็ด ๅ | B | Immunotech SAS, A Beckman Coulter Company Beckman Coulter, Inc. | Jul 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Bone Metabolism Marker, Bone Alkaline Phosphatase ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ้ชจไปฃ่ฐขๆ ๅฟ็ฉใ้ชจ็ขฑๆง็ฃท้
ธ้
ถ | B | Beckman Coulter, Inc. Beckman Coulter, Inc. | Jul 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Anemia Test, Erythropoietin ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่ดซ่กๆฃๆตใไฟ็บข็ป่็ๆ็ด | B | Beckman Coulter, Inc. Beckman Coulter, Inc. | Jul 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Renal Metabolism, Cortisol ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่พ่ไปฃ่ฐขใ็ฎ่ดจ้ | B | Beckman Coulter, Inc. Beckman Coulter, Inc. | Jul 24, 2024 |
Risk Class Distribution
B22
C9
D4
Applicant Partnerships
Top manufacturers represented by this AR.
Beckman Coulter, Inc.32
Immunotech SAS, A Beckman Coulter Company2
Immunotech S.A.S., A Beckman Coulter
Company1
Timeline
First Representation
Nov 18, 2020
Most Recent
Sep 24, 2024