Authorised representative (AR)

Roche Diagnostics (Hong Kong) Limited

Hong Kong MDACS·174 represented devices·9 applicants·Dec 11, 2007Oct 16, 2024
174
Total devices
9
Applicants
2007
First representation
2024
Most recent
AR overview
Bilingual authorised representative information and contact details
Authorised representative (EN)
Roche Diagnostics (Hong Kong) Limited
Phone
24813387
Timeline
First representation
Dec 11, 2007
Most recent
Oct 16, 2024
Risk class distribution
D
17
B
83
C
63
II
11
Applicant partnerships
Top manufacturers represented by this AR
Recent registrations
Latest 15 MDACS listings represented by Roche Diagnostics (Hong Kong) Limited
DeviceRisk classApplicantRegistered
IVD Test Reagent/Kits, Microbiology, Virus, Identification, Herpes Simplex
体外诊断检测试剂/试剂盒, 微生物学, 病毒, 鉴定, 单纯疱疹病毒
CRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Oct 16, 2024
IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, C3/C3c
体外诊断检测试剂/试剂盒, 免疫测定, 蛋白质, 补体成分, C3/C3c
BRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Oct 16, 2024
IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry
体外诊断检测试剂/试剂盒, 免疫细胞化学/免疫组化
BVentana Medical Systems, Inc.
Ventana Medical Systems,Inc.
Oct 16, 2024
IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-1-Antitrypsin
体外诊断检测试剂/试剂盒, 免疫检测, 蛋白质, α-1-抗胰蛋白酶
BRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Oct 16, 2024
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antibody
体外诊断 检测试剂/试剂盒, 血清学, 病毒, 严重急性呼吸综合征冠状病毒 2, 抗体
CRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Oct 16, 2024
IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme
体外诊断检测试剂/试剂盒、临床化学、酶、乳酸脱氢酶、同工酶
BRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Oct 16, 2024
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A
体外诊断 测试试剂/试剂盒、免疫测定、蛋白质、免疫球蛋白A
BRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Oct 16, 2024
IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Stain
体外诊断检测试剂/试剂盒, 免疫细胞化学/免疫组化, 染色
BVentana Medical Systems Inc
Ventana Medical Systems,Inc.
Oct 16, 2024
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C
体外诊断检测试剂/试剂盒, 血清学, 病毒, 丙型肝炎
DRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Oct 16, 2024
IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency
体外诊断面板, 人类遗传学, 免疫缺陷, 原发性抗体缺乏症
BVentana Medical Systems, Inc.
Ventana Medical Systems,Inc.
Oct 16, 2024
IVD Panels, Human Genetics, Immunodeficiency, Primary Antibody Deficiency
体外诊断面板, 人类遗传学, 免疫缺陷, 原发性抗体缺乏症
CVentana Medical Systems, Inc.
Ventana Medical Systems,Inc.
Oct 16, 2024
IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1
体外诊断检测试剂/试剂盒, 免疫细胞化学/免疫组化, 肿瘤标志物, PD-L1
CRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Vitamin, Folate
体外诊断 测试试剂/试剂盒、免疫测定、维生素、叶酸
BRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Sep 24, 2024
IVD Test Reagent/Kits, Clinical Chemistry, Rapid Test, Urine
体外诊断 检测试剂/试剂盒, 临床化学, 快速检测, 尿液
BRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Endocrine Hormone, Growth Hormone
体外诊断 测试试剂/试剂盒,免疫测定,内分泌激素,生长激素
BRoche Diagnostics GmbH
Roche Diagnostics Gmbh
Sep 24, 2024
About this profile

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.