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7 Devices

Hologic, Inc. - Applicant Profile

Hologic

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.

3 Risk Classes
Since 2010
Latest 2023
Applicant Overview
Bilingual manufacturer details sourced from Hong Kong MDACS.
Applicant (EN)
Hologic, Inc.
Country
United States
็พŽๅ›ฝ
Applicant (ZH)
Hologic
Address
36, Apple Ridge Road, Danbury, CT 06810, USA
36, ่‹นๆžœๅฒญ่ทฏ, ไธนไผฏ้‡Œ, CT 06810, ็พŽๅ›ฝ
Recent MDACS Registrations
Latest 15 devices linked to this applicant.
DeviceRisk ClassAuthorised RepRegistered
Radiographic Systems, Digital, Mammographic
ๆ”พๅฐ„ๆˆๅƒ็ณป็ปŸ,ๆ•ฐๅญ—,ไนณ่…บ X ็บฟๆ‘„ๅฝฑ
III
Prism Technologies Limited
ๆฃฑ็ง‘ๆœ‰้™ๅ…ฌๅธ
Jan 19, 2023
IVD Test Reagent/Kits, Molecular Assay, Infection, Virus, West Nile Virus, RNA
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅˆ†ๅญๆฃ€ๆต‹ใ€ๆ„ŸๆŸ“ใ€็—…ๆฏ’ใ€่ฅฟๅฐผ็ฝ—ๆฒณ็—…ๆฏ’ใ€RNA
D
Grifols (HK) Limited
Oct 25, 2016
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅˆ†ๅญๆฃ€ๆต‹่ฏ•ๅ‰‚็›’ใ€ๆ ธ้…ธๆŽข้’ˆ
D
Grifols (HK) Limited
Aug 23, 2016
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Probe
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅˆ†ๅญๆฃ€ๆต‹่ฏ•ๅ‰‚็›’ใ€ๆ ธ้…ธๆŽข้’ˆ
D
Grifols (HK) Limited
Sep 24, 2015
IVD Test Reagent/Kits, Molecular Assay, Nucleic Acid Processing, Replication
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅˆ†ๅญๆฃ€ๆต‹ใ€ๆ ธ้…ธๅค„็†ใ€ๅคๅˆถ
D
Grifols (HK) Limited
Aug 05, 2015
Morcellators, Endoscopic, Gynecology
ๅˆ†็ขŽๅ™จใ€ๅ†…็ชฅ้•œใ€ๅฆ‡็ง‘
II
Hologic Asia Pacific Limited
็พŽๅ›ฝ่ฑชๆด›ๆทไบšๅคชๆœ‰้™ๅ…ฌๅธ
Dec 27, 2013
Radiofrequency Therapy Systems, Tissue Ablation, Endometrial
ๅฐ„้ข‘ๆฒป็–—็ณป็ปŸใ€็ป„็ป‡ๆถˆ่žใ€ๅญๅฎซๅ†…่†œ
III
Hologic Asia Pacific Limited
็พŽๅ›ฝ่ฑชๆด›ๆทไบšๅคชๆœ‰้™ๅ…ฌๅธ
Oct 22, 2010
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Risk Class Breakdown
D4
II1
III2
Timeline
First Registration
Oct 22, 2010
Most Recent
Jan 19, 2023