Authorised representative profile

Roche Diagnostics (Hong Kong) Limited

Hong Kong MDACS174 represented devices9 applicantsDec 11, 2007 – Oct 16, 2024

VerifiedMDD (Medical Device Division) · MDACS registry

174

Total devices

9

Applicants

2007

First representation

2024

Most recent

AR overview

Authorised representative (EN): Roche Diagnostics (Hong Kong) Limited
Phone: 24813387

Timeline

First representation: Dec 11, 2007
Most recent: Oct 16, 2024

Regulatory footprint

Search Roche Diagnostics (Hong Kong) Limited across other regulatory registries

Risk class distribution

D17

B83

C63

II11

Applicant partnerships

Top manufacturers represented by this AR

Roche Diagnostics GmbH

Roche Molecular Systems, Inc.

Roche Diabetes Care GmbH

Ventana Medical Systems, Inc.

SD Biosensor, Inc.

Roche Diagnostics GmbH (Diabetes Care)

Roche Diagnostic GmbH

HTL-STREFA S.A.

Ventana Medical Systems Inc

Recent registrations

Latest 15 MDACS listings represented by Roche Diagnostics (Hong Kong) Limited

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

Risk class: C
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: B
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: B
Applicant: Ventana Medical Systems, Inc.Ventana Medical Systems,Inc.

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

Risk class: B
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: C
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: B
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: B
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: B
Applicant: Ventana Medical Systems IncVentana Medical Systems,Inc.

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

Risk class: D
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: B
Applicant: Ventana Medical Systems, Inc.Ventana Medical Systems,Inc.

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

Risk class: C
Applicant: Ventana Medical Systems, Inc.Ventana Medical Systems,Inc.

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

Risk class: C
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: B
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: B
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

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

Risk class: B
Applicant: Roche Diagnostics GmbHRoche Diagnostics Gmbh

View all 174 devices →

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.