Applicant profile

Roche Diagnostics GmbH

Roche Diagnostics Gmbh

Hong Kong MDACSGermany143 registered devicesDec 11, 2007 – Oct 16, 2024

VerifiedMDD (Medical Device Division) · MDACS registry

143

Total devices

4

Risk classes

2007

First registration

2024

Most recent

Applicant overview

Applicant (EN): Roche Diagnostics GmbH
Applicant (ZH): Roche Diagnostics Gmbh
Country: Germany
Address: Sandhofer Strasse 116, 68305 Mannheim, Germany

Timeline

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

Regulatory footprint

Search Roche Diagnostics GmbH across other regulatory registries

Risk class breakdown

D11

B78

C47

II7

Recent MDACS registrations

Latest 15 devices linked to this applicant

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
Authorised rep: 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
Authorised rep: Roche Diagnostics (Hong Kong) Limited

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
Authorised rep: Roche Diagnostics (Hong Kong) Limited

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
Authorised rep: Roche Diagnostics (Hong Kong) Limited

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
Authorised rep: Roche Diagnostics (Hong Kong) Limited

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
Authorised rep: Roche Diagnostics (Hong Kong) Limited

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
Authorised rep: Roche Diagnostics (Hong Kong) Limited

IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Tacrolimus

体外诊断检测试剂/试剂盒, 免疫测定, 治疗药物, 免疫抑制剂, 他克莫司

Risk class: C
Authorised rep: Roche Diagnostics (Hong Kong) Limited

IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin

体外诊断测试试剂/试剂盒、免疫测定、妊娠激素、人绒毛膜促性腺激素

Risk class: B
Authorised rep: Roche Diagnostics (Hong Kong) Limited

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
Authorised rep: Roche Diagnostics (Hong Kong) Limited

IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Androstenedione

体外诊断检测试剂/试剂盒, 免疫测定, 生育激素, 雄烯二酮

Risk class: B
Authorised rep: Roche Diagnostics (Hong Kong) Limited

IVD Test Reagent/Kits, Immunoassay, Endocrine, Insulin-Like Growth Factor Binding Protein 3

体外诊断检测试剂/试剂盒, 免疫测定, 内分泌, 胰岛素样生长因子结合蛋白 3

Risk class: B
Authorised rep: Roche Diagnostics (Hong Kong) Limited

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
Authorised rep: Roche Diagnostics (Hong Kong) Limited

IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Valproic Acid

体外诊断检测试剂/试剂盒, 免疫测定, 治疗药物, 抗惊厥药, 丙戊酸

Risk class: C
Authorised rep: Roche Diagnostics (Hong Kong) Limited

IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid

体外诊断检测试剂/试剂盒, 临床化学, 总蛋白质, 脑脊液

Risk class: B
Authorised rep: Roche Diagnostics (Hong Kong) Limited

View all 143 devices →

About this profile

Roche Diagnostics GmbH is associated with 143 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.