Authorised representative profileAbbott Laboratories Limited
美国雅培制药有限公司
Hong Kong MDACS89 represented devices14 applicantsDec 11, 2007 – Sep 11, 2024
VerifiedMDD (Medical Device Division) · MDACS registry
89
Total devices
14
Applicants
2007
First representation
2024
Most recent
AR overview
- Authorised representative (EN)
- Abbott Laboratories Limited
- Authorised representative (ZH)
- 美国雅培制药有限公司
- Phone
- 25668711, 98615786
Timeline
- First representation
- Dec 11, 2007
- Most recent
- Sep 11, 2024
Regulatory footprint
Search Abbott Laboratories Limited across other regulatory registries
Thailand
European Union
Colombia
South Korea
Canada
EcuadorRisk class distribution
D43
B2
C12
II6
III3
IV23
Applicant partnerships
Top manufacturers represented by this AR
Abbott Vascular
23 devices
Abbott GmbH & Co. KG
21 devices
Abbott Ireland Diagnostics Division
17 devices
Abbott Ireland, Diagnostics Division
8 devices
Abbott GmbH
5 devices
Abbott Laboratories, Vascular Enterprises Ltd., Dublin, Beringen Branch
3 devices
Abbott Ireland, Diagnostic Division
2 devices
Abbott Laboratories Vascular Enterprises Ltd., Dublin, Beringen Branch
2 devices
Abbott Rapid Diagnostics Jena GmbH
2 devices
Abbott Diagnostics Scarborough, Inc.
2 devices
Recent registrations
Latest 15 MDACS listings represented by Abbott Laboratories Limited
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin
体外诊断 测试试剂/试剂盒、免疫测定、甲状腺激素、促甲状腺素
Sep 11, 2024
- Risk class
- B
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen
体外诊断 检测试剂/试剂盒、免疫测定、肿瘤标志物、酶、前列腺特异性抗原
Aug 08, 2024
- Risk class
- C
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、乙型肝炎、表面抗体
Aug 08, 2024
- Risk class
- D
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein
体外诊断 测试试剂/试剂盒、免疫测定、妊娠蛋白、甲胎蛋白
Aug 08, 2024
- Risk class
- C
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
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
Aug 08, 2024
- Risk class
- D
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen
体外诊断 检测试剂/试剂盒、免疫测定、肿瘤标志物、酶、前列腺特异性抗原
Aug 08, 2024
- Risk class
- C
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin
体外诊断 测试试剂/试剂盒、免疫测定、甲状腺激素、促甲状腺素
Aug 08, 2024
- Risk class
- B
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Carcinoembryonic Antigen
体外诊断 检测试剂/试剂盒、免疫测定、肿瘤标志物、肿瘤胎儿、癌胚抗原
Aug 08, 2024
- Risk class
- C
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
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
Jul 24, 2024
- Risk class
- D
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
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
Jul 24, 2024
- Risk class
- D
- Applicant
- Abbott Ireland Diagnostics DivisionAbbott Ireland Diagnostics Division
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core Antigen
体外诊断 检测试剂/试剂盒、血清学、病毒、丙型肝炎、核心抗原
Jul 24, 2024
- Risk class
- D
- Applicant
- Abbott GmbH & Co. KGAbbott Gmbh
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
Jul 24, 2024
- Risk class
- D
- Applicant
- Abbott GmbH & Co. KGAbbott Gmbh
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus-I/II, Antibody
体外诊断 检测试剂/试剂盒、血清学、病毒、逆转录病毒、人 T 细胞嗜淋巴细胞病毒-I/II、抗体
Jul 24, 2024
- Risk class
- D
- Applicant
- Abbott GmbH & Co. KGAbbott Gmbh
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Legionella Pneumophila, Antigen
体外诊断检测试剂/试剂盒、免疫测定、快速检测、细菌、嗜肺军团菌、抗原
Jul 23, 2024
- Risk class
- C
- Applicant
- Abbott Diagnostics Scarborough, Inc.Abbott
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigen
体外诊断检测试剂/试剂盒, 免疫测定, 快速检测, 细菌, 肺炎链球菌, 抗原
Jul 23, 2024
- Risk class
- C
- Applicant
- Abbott Diagnostics Scarborough, Inc.Abbott
About this profile
Abbott Laboratories Limited serves as the authorised representative for 89 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.