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Applicant profile

Abbott Ireland, Diagnostics Division

Abbott Ireland Diagnostics Division
Hong Kong MDACSIreland8 registered devicesNov 03, 2022 – Oct 26, 2023
VerifiedMDD (Medical Device Division) · MDACS registry
8
Total devices
2
Risk classes
2022
First registration
2023
Most recent
Applicant overview
Applicant (EN)
Abbott Ireland, Diagnostics Division
Applicant (ZH)
Abbott Ireland Diagnostics Division
Country
Ireland
爱尔兰
Address
Finisklin Business Park, Sligo, Ireland
菲尼斯克林商业园,爱尔兰斯莱戈
Timeline
First registration
Nov 03, 2022
Most recent
Oct 26, 2023
Regulatory footprint
Search Abbott Ireland, Diagnostics Division across other regulatory registries
Risk class breakdown
C2
D6
Recent MDACS registrations
Latest 15 devices linked to this applicant
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
Oct 26, 2023
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
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
Oct 25, 2023
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
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
Oct 25, 2023
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
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
Oct 25, 2023
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
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
Oct 25, 2023
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
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
Mar 03, 2023
Risk class
D
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin I
体外诊断 测试试剂/试剂盒、免疫测定、心脏标志物、蛋白质、肌钙蛋白 I
Nov 03, 2022
Risk class
C
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
IVD Test Reagent/Kits, Immunoassay, Cardiac Marker, Protein, Troponin-I
体外诊断 测试试剂/试剂盒、免疫测定、心脏标志物、蛋白质、肌钙蛋白-I
Nov 03, 2022
Risk class
C
Authorised rep
Abbott Laboratories Limited美国雅培制药有限公司
About this profile

Abbott Ireland, Diagnostics Division is associated with 8 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.