Applicant profileHologic, Inc.
Hologic
Hong Kong MDACSUnited States7 registered devicesOct 22, 2010 – Jan 19, 2023
VerifiedMDD (Medical Device Division) · MDACS registry
7
Total devices
3
Risk classes
2010
First registration
2023
Most recent
Applicant overview
- Applicant (EN)
- Hologic, Inc.
- Applicant (ZH)
- Hologic
- Country
- United States
- Address
- 36, Apple Ridge Road, Danbury, CT 06810, USA
美国
36, 苹果岭路, 丹伯里, CT 06810, 美国
Timeline
- First registration
- Oct 22, 2010
- Most recent
- Jan 19, 2023
Regulatory footprint
Search Hologic, Inc. across other regulatory registries
Thailand
European Union
Colombia
South Korea
Canada
EcuadorRisk class breakdown
D4
II1
III2
Recent MDACS registrations
Latest 15 devices linked to this applicant
Radiographic Systems, Digital, Mammographic
放射成像系统,数字,乳腺 X 线摄影
Jan 19, 2023
- Risk class
- III
- Authorised rep
- Prism Technologies Limited棱科有限公司
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, West Nile Virus, RNA
体外诊断 检测试剂/试剂盒、分子检测、感染、病毒、西尼罗河病毒、RNA
Oct 25, 2016
- Risk class
- D
- Authorised rep
- Grifols (HK) Limited
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
体外诊断 检测试剂/试剂盒、分子检测试剂盒、核酸探针
Aug 23, 2016
- Risk class
- D
- Authorised rep
- Grifols (HK) Limited
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
体外诊断 检测试剂/试剂盒、分子检测试剂盒、核酸探针
Sep 24, 2015
- Risk class
- D
- Authorised rep
- Grifols (HK) Limited
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Replication
体外诊断 检测试剂/试剂盒、分子检测、核酸处理、复制
Aug 05, 2015
- Risk class
- D
- Authorised rep
- Grifols (HK) Limited
Morcellators, Endoscopic, Gynecology
分碎器、内窥镜、妇科
Dec 27, 2013
- Risk class
- II
- Authorised rep
- Hologic Asia Pacific Limited美国豪洛捷亚太有限公司
Radiofrequency Therapy Systems, Tissue Ablation, Endometrial
射频治疗系统、组织消融、子宫内膜
Oct 22, 2010
- Risk class
- III
- Authorised rep
- Hologic Asia Pacific Limited美国豪洛捷亚太有限公司
About this profile
Hologic, Inc. 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.