174 Devices
Roche Diagnostics (Hong Kong) Limited - Authorised Representative (AR)
Roche Diagnostics (Hong Kong) Limited serves as the authorised representative for 174 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 2007
Latest 2024
AR Overview
Bilingual authorised representative information and contact details.
Authorised Representative (EN)
Roche Diagnostics (Hong Kong) Limited
24813387
Recent Registrations
Latest 15 MDACS listings represented by Roche Diagnostics (Hong Kong) Limited.
| Device | Risk Class | Applicant | Registered |
|---|---|---|---|
| IVD Test Reagent/Kits, Microbiology, Virus, Identification, Herpes Simplex ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅพฎ็็ฉๅญฆ, ็
ๆฏ, ้ดๅฎ, ๅ็บฏ็ฑ็น็
ๆฏ | C | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Oct 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, C3/C3c ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ
็ซๆตๅฎ, ่็ฝ่ดจ, ่กฅไฝๆๅ, C3/C3c | B | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Oct 16, 2024 |
| IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ
็ซ็ป่ๅๅญฆ/ๅ
็ซ็ปๅ | B | Ventana Medical Systems, Inc. Ventana Medical Systems,Inc. | Oct 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-1-Antitrypsin ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ
็ซๆฃๆต, ่็ฝ่ดจ, ฮฑ-1-ๆ่ฐ่็ฝ้
ถ | B | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Oct 16, 2024 |
| IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antibody ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็, ่กๆธ
ๅญฆ, ็
ๆฏ, ไธฅ้ๆฅๆงๅผๅธ็ปผๅๅพๅ ็ถ็
ๆฏ 2, ๆไฝ | C | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Oct 16, 2024 |
| IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใไธดๅบๅๅญฆใ้
ถใไนณ้
ธ่ฑๆฐข้
ถใๅๅทฅ้
ถ | B | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Oct 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝA | B | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Oct 16, 2024 |
| IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Stain ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ
็ซ็ป่ๅๅญฆ/ๅ
็ซ็ปๅ, ๆ่ฒ | B | Ventana Medical Systems Inc Ventana Medical Systems,Inc. | Oct 16, 2024 |
| IVD Test Reagent/Kits, Serology, Virus, Hepatitis C ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ่กๆธ
ๅญฆ, ็
ๆฏ, ไธๅ่็ | D | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Oct 16, 2024 |
| IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency ไฝๅค่ฏๆญ้ขๆฟ, ไบบ็ฑป้ไผ ๅญฆ, ๅ
็ซ็ผบ้ท, ๅๅๆงๆไฝ็ผบไน็ | B | Ventana Medical Systems, Inc. Ventana Medical Systems,Inc. | Oct 16, 2024 |
| IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency ไฝๅค่ฏๆญ้ขๆฟ, ไบบ็ฑป้ไผ ๅญฆ, ๅ
็ซ็ผบ้ท, ๅๅๆงๆไฝ็ผบไน็ | C | Ventana Medical Systems, Inc. Ventana Medical Systems,Inc. | Oct 16, 2024 |
| IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1 ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅ
็ซ็ป่ๅๅญฆ/ๅ
็ซ็ปๅ, ่ฟ็คๆ ๅฟ็ฉ, PD-L1 | C | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Sep 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Vitamin, Folate ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ็ปด็็ด ใๅถ้
ธ | B | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Sep 24, 2024 |
| IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine ไฝๅค่ฏๆญ ๆฃๆต่ฏๅ/่ฏๅ็, ไธดๅบๅๅญฆ, ๅฟซ้ๆฃๆต, ๅฐฟๆถฒ | B | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Sep 24, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Growth Hormone ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็,ๅ
็ซๆตๅฎ,ๅ
ๅๆณๆฟ็ด ,็้ฟๆฟ็ด | B | Roche Diagnostics GmbH Roche Diagnostics Gmbh | Sep 24, 2024 |
Risk Class Distribution
D17
B83
C63
II11
Applicant Partnerships
Top manufacturers represented by this AR.
Roche Diagnostics GmbH143
Roche Molecular Systems, Inc.17
Roche Diabetes Care GmbH5
Ventana Medical Systems, Inc.3
SD Biosensor, Inc.2
Roche Diagnostics GmbH (Diabetes Care)1
Roche Diagnostic GmbH1
HTL-STREFA S.A.1
Ventana Medical Systems Inc1
Timeline
First Representation
Dec 11, 2007
Most Recent
Oct 16, 2024