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Applicant profile

Ortho-Clinical Diagnostics

Ortho-Clinical Diagnostics, Inc.
Hong Kong MDACSUnited Kingdom7 registered devicesFeb 03, 2021 – Jun 28, 2022
VerifiedMDD (Medical Device Division) · MDACS registry
7
Total devices
1
Risk classes
2021
First registration
2022
Most recent
Applicant overview
Applicant (EN)
Ortho-Clinical Diagnostics
Applicant (ZH)
Ortho-Clinical Diagnostics, Inc.
Country
United Kingdom
英国
Address
Felindre Meadows, Pencoed, Bridgend CF35 5PZ, United Kingdom
Felindre Meadows, Pencoed, Bridgend CF35 5PZ, 英国
Timeline
First registration
Feb 03, 2021
Most recent
Jun 28, 2022
Regulatory footprint
Search Ortho-Clinical Diagnostics across other regulatory registries
ThailandEuropean UnionColombiaSouth KoreaCanadaEcuador
Risk class breakdown
D7
Recent MDACS registrations
Latest 15 devices linked to this applicant
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原
Jun 28, 2022
Risk class
D
Authorised rep
DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、丙型肝炎、抗体
Feb 16, 2022
Risk class
D
Authorised rep
DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原
Dec 10, 2021
Risk class
D
Authorised rep
DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、核心抗体
Dec 10, 2021
Risk class
D
Authorised rep
DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, Confirmatory
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原、确认性
Dec 10, 2021
Risk class
D
Authorised rep
DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, Confirmatory
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗原、确认性
Dec 10, 2021
Risk class
D
Authorised rep
DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2, Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、逆转录病毒、HIV-1/2、抗体
Feb 03, 2021
Risk class
D
Authorised rep
DCH Auriga (Hong Kong) Limited奥利佳(香港)有限公司
About this profile

Ortho-Clinical Diagnostics is associated with 7 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.