34 Devices
Thermo Fisher Scientific (Hong Kong) Limited - Authorised Representative (AR)
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Thermo Fisher Scientific (Hong Kong) Limited serves as the authorised representative for 34 medical devices in Hong Kong's MDACS framework. Analyse applicant partnerships, risk class exposure, and recent regulatory activity to understand their market footprint.
10 Applicants
Since 2021
Latest 2024
AR Overview
Bilingual authorised representative information and contact details.
Authorised Representative (EN)
Thermo Fisher Scientific (Hong Kong) Limited
31077600
Authorised Representative (ZH)
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ฌๅธ
Recent Registrations
Latest 15 MDACS listings represented by Thermo Fisher Scientific (Hong Kong) Limited.
| Device | Risk Class | Applicant | Registered |
|---|---|---|---|
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝ G | B | PHADIA AB Phadia Ab | Sep 24, 2024 |
| IVD Test Reagent/Kits, Molecular Assay, Control, Targeted Sequencing, Human ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็, ๅๅญๆฃๆต, ๅฏน็
ง, ้ถๅๆตๅบ, ไบบ็ฑป | C | Microgenics Corporation Microgenics Corporation | Sep 11, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝ G | B | PHADIA AB Phadia Ab | Aug 29, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝ G | B | PHADIA AB Phadia Ab | Aug 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝA | B | PHADIA AB Phadia Ab | Aug 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝ G | B | PHADIA AB Phadia Ab | Aug 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝ G | B | PHADIA AB Phadia Ab | Aug 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝ M | B | PHADIA AB Phadia Ab | Aug 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝA | B | PHADIA AB Phadia Ab | Aug 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝA | B | PHADIA AB Phadia Ab | Aug 16, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin M ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝ M | B | PHADIA AB Phadia Ab | Aug 16, 2024 |
| IVD Test Reagent/Kits, Clinical Chemistry, Alcohol Level ไฝๅค่ฏๆญๆฃๆต่ฏๅ/่ฏๅ็ใไธดๅบๅๅญฆใ้
็ฒพๅซ้ | B | Microgenics Corporation Microgenics Corporation | Aug 08, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝA | B | PHADIA AB Phadia Ab | Jul 23, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝA | B | PHADIA AB Phadia Ab | Jul 23, 2024 |
| IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin G ไฝๅค่ฏๆญ ๆต่ฏ่ฏๅ/่ฏๅ็ใๅ
็ซๆตๅฎใ่็ฝ่ดจใๅ
็ซ็่็ฝ G | B | PHADIA AB Phadia Ab | Jul 23, 2024 |
Risk Class Distribution
B27
C5
II2
Applicant Partnerships
Top manufacturers represented by this AR.
PHADIA AB22
Microgenics Corporation2
Remel Europe Ltd.2
Thermo Fisher Scientific (Asheville) LLC2
B.R.A.H.M.S. GmbH1
Oxoid Limited1
Oxoid Ltd.1
Remel, Inc.1
Thermo Fisher Scientific Oy1
Trek Diagnostic Systems Ltd.1
Timeline
First Representation
Feb 10, 2021
Most Recent
Sep 24, 2024