Pure Global
21 Devices

Bio-Rad Pacific Limited - Authorised Representative (AR)

Bio-Rad Pacific Limited serves as the authorised representative for 21 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.

7 Applicants
Since 2014
Latest 2024
AR Overview
Bilingual authorised representative information and contact details.
Authorised Representative (EN)
Bio-Rad Pacific Limited
2789 3300 / 63365950
Recent Registrations
Latest 15 MDACS listings represented by Bio-Rad Pacific Limited.
DeviceRisk ClassApplicantRegistered
IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ๆ’ๆฒณ็Œดๅˆ†ๅž‹
D
Bio-Rad Medical Diagnostics GmbH
Bio-Rad Medical Diagnostics GmbH
Oct 16, 2024
IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ๆ’ๆฒณ็Œดๅˆ†ๅž‹
C
Bio-Rad Medical Diagnostics GmbH
Bio-Rad Medical Diagnostics GmbH
Oct 16, 2024
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1/2
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€้€†่ฝฌๅฝ•็—…ๆฏ’ใ€HIV-1/2
D
BIO-RAD LABORATORIES CLINICAL DIAGNOSTICS GROUP
BIO-RAD LABORATORIES CLINICAL DIAGNOSTICS GROUP
Oct 07, 2024
IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Antiglobulin, Polyspecific
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซ่ก€ๆถฒๅญฆ, ๆŠ—ไฝ“ๆฃ€ๆต‹/้‰ดๅฎš, ๆŠ—ไบบ็ƒ่›‹็™ฝ, ๅคš็‰นๅผ‚ๆ€ง
C
Bio-Rad Medical Diagnostics GmbH
Bio-Rad Medical Diagnostics GmbH
Sep 11, 2024
IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ๆ’ๆฒณ็Œดๅˆ†ๅž‹
D
Bio-Rad Medical Diagnostics GmbH
Bio-Rad Medical Diagnostics GmbH
Aug 08, 2024
IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ๆ’ๆฒณ็Œดๅˆ†ๅž‹
D
DiaMed GmbH
Diamed Gmbh
Aug 08, 2024
IVD Test Reagent/Kits, Immunohematology, Blood Grouping, Rhesus Typing
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ๆ’ๆฒณ็Œดๅˆ†ๅž‹
D
Bio-Rad Medical Diagnostics GmbH
Bio-Rad Medical Diagnostics GmbH
Aug 08, 2024
IVD Test Reagent/Kits, Serology, Control, Virus
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€ๅฏน็…งใ€็—…ๆฏ’
D
BIO RAD LABORATORIES, Clinical Diagnostics Group
BIO RAD LABORATORIES, Clinical Diagnostics Group
May 22, 2024
IVD Test Reagent/Kits, Serology, Control, Virus
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€ๅฏน็…งใ€็—…ๆฏ’
D
Bio-Rad Laboratories Inc.
Bio-Rad
May 22, 2024
IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ABO ๅˆ†ๅž‹
D
DiaMed GmbH
Diamed Gmbh
Mar 21, 2024
IVD Test Reagent/Kits, Immunohematology, Antibody Detection/Identification, Antiglobulin, Polyspecific
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซ่ก€ๆถฒๅญฆ, ๆŠ—ไฝ“ๆฃ€ๆต‹/้‰ดๅฎš, ๆŠ—ไบบ็ƒ่›‹็™ฝ, ๅคš็‰นๅผ‚ๆ€ง
C
DiaMed GmbH
Diamed Gmbh
Dec 22, 2023
HIV1/HIV2 antigen/antibody IVD, kit, enzyme immunoassay (EIA)
HIV1/HIV2 ๆŠ—ๅŽŸ/ๆŠ—ไฝ“ไฝ“ๅค–่ฏŠๆ–ญใ€่ฏ•ๅ‰‚็›’ใ€้…ถๅ…็–ซๆต‹ๅฎš (EIA)
D
BIO-RAD
Bio-Rad
Feb 03, 2021
IVD Test Reagent/Kits, Serology, Virus, Retrovirus, HIV-1, Antigen
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€่ก€ๆธ…ๅญฆใ€็—…ๆฏ’ใ€้€†่ฝฌๅฝ•็—…ๆฏ’ใ€HIV-1ใ€ๆŠ—ๅŽŸ
D
BIO-RAD
Bio-Rad
Dec 08, 2020
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
BIO-RAD
Bio-Rad
Dec 03, 2020
IVD Test Reagent/Kits, Immunohematology, Blood Grouping, ABO Typing
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซ่ก€ๆถฒๅญฆใ€่ก€ๅž‹ใ€ABO ๅˆ†ๅž‹
D
DiaMed Holding GmbH
DiaMed Holding GmbH
Nov 11, 2020
Pure Global
DJ Fang

DJ Fang

MedTech Regulatory Expert

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Pricing
Risk Class Distribution
C3
D18
Applicant Partnerships
Top manufacturers represented by this AR.
BIO-RAD6
Bio-Rad Medical Diagnostics GmbH5
DiaMed Holding GmbH4
DiaMed GmbH3
BIO RAD LABORATORIES, Clinical Diagnostics Group1
BIO-RAD LABORATORIES CLINICAL DIAGNOSTICS GROUP1
Bio-Rad Laboratories Inc.1
Timeline
First Representation
Jul 23, 2014
Most Recent
Oct 16, 2024