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Applicant profile

Roche Diagnostic GmbH

Roche Diagnostics Gmbh
Hong Kong MDACSGermany1 registered deviceAug 16, 2024 – Aug 16, 2024
VerifiedMDD (Medical Device Division) · MDACS registry
1
Total devices
1
Risk classes
2024
First registration
2024
Most recent
Applicant overview
Applicant (EN)
Roche Diagnostic 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
Aug 16, 2024
Most recent
Aug 16, 2024
Regulatory footprint
Search Roche Diagnostic GmbH across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Risk class breakdown
B1
Recent MDACS registrations
Latest 15 devices linked to this applicant
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Follicle Stimulating Hormone
体外诊断 测试试剂/试剂盒、免疫测定、生育激素、促卵泡激素
Aug 16, 2024
Risk class
B
Authorised rep
Roche Diagnostics (Hong Kong) Limited
About this profile

Roche Diagnostic GmbH is associated with 1 medical device registered under the Hong Kong Medical Device Administrative Control System (MDACS). Explore bilingual product names, risk classes, authorised representatives, and life-cycle milestones.