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89 Devices

Abbott Laboratories Limited - Authorised Representative (AR)

็พŽๅ›ฝ้›…ๅŸนๅˆถ่ฏๆœ‰้™ๅ…ฌๅธ

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.

14 Applicants
Since 2007
Latest 2024
AR Overview
Bilingual authorised representative information and contact details.
Authorised Representative (EN)
Abbott Laboratories Limited
25668711, 98615786
Authorised Representative (ZH)
็พŽๅ›ฝ้›…ๅŸนๅˆถ่ฏๆœ‰้™ๅ…ฌๅธ
Recent Registrations
Latest 15 MDACS listings represented by Abbott Laboratories Limited.
DeviceRisk ClassApplicantRegistered
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€็”ฒ็Šถ่…บๆฟ€็ด ใ€ไฟƒ็”ฒ็Šถ่…บ็ด 
B
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Sep 11, 2024
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่‚ฟ็˜คๆ ‡ๅฟ—็‰ฉใ€้…ถใ€ๅ‰ๅˆ—่…บ็‰นๅผ‚ๆ€งๆŠ—ๅŽŸ
C
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Aug 08, 2024
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antibody
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไน™ๅž‹่‚็‚Žใ€่กจ้ขๆŠ—ไฝ“
D
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Aug 08, 2024
IVD Test Reagent/Kits, Immunoassay, Pregnancy Protein, Alpha-Fetoprotein
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€ๅฆŠๅจ ่›‹็™ฝใ€็”ฒ่ƒŽ่›‹็™ฝ
C
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Aug 08, 2024
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไน™ๅž‹่‚็‚Žใ€่กจ้ขๆŠ—ๅŽŸ
D
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Aug 08, 2024
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Enzyme, Prostate Specific Antigen
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่‚ฟ็˜คๆ ‡ๅฟ—็‰ฉใ€้…ถใ€ๅ‰ๅˆ—่…บ็‰นๅผ‚ๆ€งๆŠ—ๅŽŸ
C
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Aug 08, 2024
IVD Test Reagent/Kits, Immunoassay, Thyroid Hormone, Thyrotropin
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€็”ฒ็Šถ่…บๆฟ€็ด ใ€ไฟƒ็”ฒ็Šถ่…บ็ด 
B
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Aug 08, 2024
IVD Test Reagent/Kits, Immunoassay, Tumor Marker, Oncofetal, Carcinoembryonic Antigen
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่‚ฟ็˜คๆ ‡ๅฟ—็‰ฉใ€่‚ฟ็˜ค่ƒŽๅ„ฟใ€็™Œ่ƒšๆŠ—ๅŽŸ
C
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Aug 08, 2024
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen, Confirmatory
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไน™ๅž‹่‚็‚Žใ€่กจ้ขๆŠ—ๅŽŸใ€็กฎ่ฎคๆ€ง
D
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Jul 24, 2024
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Surface Antigen
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไน™ๅž‹่‚็‚Žใ€่กจ้ขๆŠ—ๅŽŸ
D
Abbott Ireland Diagnostics Division
Abbott Ireland Diagnostics Division
Jul 24, 2024
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C, Core Antigen
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไธ™ๅž‹่‚็‚Žใ€ๆ ธๅฟƒๆŠ—ๅŽŸ
D
Abbott GmbH & Co. KG
Abbott Gmbh
Jul 24, 2024
IVD Test Reagent/Kits, Serology, Virus, Hepatitis B, Core Antibody
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€ไน™ๅž‹่‚็‚Žใ€ๆ ธๅฟƒๆŠ—ไฝ“
D
Abbott GmbH & Co. KG
Abbott Gmbh
Jul 24, 2024
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, Human T-Cell Lymphotropic Virus-I/II, Antibody
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€้€†่ฝฌๅฝ•็—…ๆฏ’ใ€ไบบ T ็ป†่ƒžๅ—œๆท‹ๅทด็ป†่ƒž็—…ๆฏ’-I/IIใ€ๆŠ—ไฝ“
D
Abbott GmbH & Co. KG
Abbott Gmbh
Jul 24, 2024
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Legionella Pneumophila, Antigen
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€ๅฟซ้€Ÿๆฃ€ๆต‹ใ€็ป†่Œใ€ๅ—œ่‚บๅ†›ๅ›ข่Œใ€ๆŠ—ๅŽŸ
C
Abbott Diagnostics Scarborough, Inc.
Abbott
Jul 23, 2024
IVD Test Reagent/Kits, Immunoassay, Rapid Test, Bacteria, Streptococcus Pneumoniae, Antigen
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซๆต‹ๅฎš, ๅฟซ้€Ÿๆฃ€ๆต‹, ็ป†่Œ, ่‚บ็‚Ž้“พ็ƒ่Œ, ๆŠ—ๅŽŸ
C
Abbott Diagnostics Scarborough, Inc.
Abbott
Jul 23, 2024
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Risk Class Distribution
D43
B2
C12
II6
III3
IV23
Applicant Partnerships
Top manufacturers represented by this AR.
Abbott Vascular23
Abbott GmbH & Co. KG21
Abbott Ireland Diagnostics Division17
Abbott Ireland, Diagnostics Division8
Abbott GmbH5
Abbott Laboratories, Vascular Enterprises Ltd., Dublin, Beringen Branch3
Abbott Ireland, Diagnostic Division2
Abbott Laboratories Vascular Enterprises Ltd., Dublin, Beringen Branch2
Abbott Rapid Diagnostics Jena GmbH2
Abbott Diagnostics Scarborough, Inc.2
Timeline
First Representation
Dec 11, 2007
Most Recent
Sep 11, 2024