Applicant profile

Roche Diagnostics GmbH

Roche Diagnostics Gmbh

Hong Kong MDACS·Germany·143 registered devices·Dec 11, 2007 – Oct 16, 2024

143

Total devices

Risk classes

2007

First registration

2024

Most recent

Applicant overview

Bilingual manufacturer details sourced from Hong Kong MDACS

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

Timeline

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

Risk class breakdown

Recent MDACS registrations

Latest 15 devices linked to this applicant

Device	Risk class	Authorised rep	Registered
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	D	Roche Diagnostics (Hong Kong) Limited	Oct 16, 2024
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	C	Roche Diagnostics (Hong Kong) Limited	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	B	Roche Diagnostics (Hong Kong) Limited	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	B	Roche Diagnostics (Hong Kong) Limited	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	B	Roche Diagnostics (Hong Kong) Limited	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	C	Roche Diagnostics (Hong Kong) Limited	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	B	Roche Diagnostics (Hong Kong) Limited	Oct 16, 2024
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	C	Roche Diagnostics (Hong Kong) Limited	Sep 24, 2024
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	B	Roche Diagnostics (Hong Kong) Limited	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	B	Roche Diagnostics (Hong Kong) Limited	Sep 24, 2024
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	B	Roche Diagnostics (Hong Kong) Limited	Sep 24, 2024
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	B	Roche Diagnostics (Hong Kong) Limited	Sep 24, 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	C	Roche Diagnostics (Hong Kong) Limited	Sep 24, 2024
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	C	Roche Diagnostics (Hong Kong) Limited	Sep 24, 2024
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	B	Roche Diagnostics (Hong Kong) Limited	Sep 24, 2024

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.