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143 Devices

Roche Diagnostics GmbH - Applicant Profile

Roche Diagnostics Gmbh

Roche Diagnostics GmbH is associated with 143 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.

4 Risk Classes
Since 2007
Latest 2024
Applicant Overview
Bilingual manufacturer details sourced from Hong Kong MDACS.
Applicant (EN)
Roche Diagnostics GmbH
Country
Germany
ๅพทๅ›ฝ
Applicant (ZH)
Roche Diagnostics Gmbh
Address
Sandhofer Strasse 116, 68305 Mannheim, Germany
Sandhofer Strasse 116, 68305 ๆ›ผๆตทๅง†, ๅพทๅ›ฝ
Recent MDACS Registrations
Latest 15 devices linked to this applicant.
DeviceRisk ClassAuthorised RepRegistered
IVD Test Reagent/Kits, Serology, Virus, Hepatitis C
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ่ก€ๆธ…ๅญฆ, ็—…ๆฏ’, ไธ™ๅž‹่‚็‚Ž
D
Roche Diagnostics (Hong Kong) Limited
Oct 16, 2024
IVD Test Reagent/Kits, Microbiology, Virus, Identification, Herpes Simplex
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅพฎ็”Ÿ็‰ฉๅญฆ, ็—…ๆฏ’, ้‰ดๅฎš, ๅ•็บฏ็–ฑ็–น็—…ๆฏ’
C
Roche Diagnostics (Hong Kong) Limited
Oct 16, 2024
IVD Test Reagent/Kits, Immunoassay, Protein, Complement Component, C3/C3c
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซๆต‹ๅฎš, ่›‹็™ฝ่ดจ, ่กฅไฝ“ๆˆๅˆ†, C3/C3c
B
Roche Diagnostics (Hong Kong) Limited
Oct 16, 2024
IVD Test Reagent/Kits, Immunoassay, Protein, Alpha-1-Antitrypsin
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซๆฃ€ๆต‹, ่›‹็™ฝ่ดจ, ฮฑ-1-ๆŠ—่ƒฐ่›‹็™ฝ้…ถ
B
Roche Diagnostics (Hong Kong) Limited
Oct 16, 2024
IVD Test Reagent/Kits, Clinical Chemistry, Enzyme, Lactate Dehydrogenase, Isoenzyme
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ไธดๅบŠๅŒ–ๅญฆใ€้…ถใ€ไนณ้…ธ่„ฑๆฐข้…ถใ€ๅŒๅทฅ้…ถ
B
Roche Diagnostics (Hong Kong) Limited
Oct 16, 2024
IVD Test Reagent/Kits, Serology, Virus, Severe Acute Respiratory Syndrome Coronavirus 2, Antibody
ไฝ“ๅค–่ฏŠๆ–ญ ๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ่ก€ๆธ…ๅญฆ, ็—…ๆฏ’, ไธฅ้‡ๆ€ฅๆ€งๅ‘ผๅธ็ปผๅˆๅพๅ† ็Šถ็—…ๆฏ’ 2, ๆŠ—ไฝ“
C
Roche Diagnostics (Hong Kong) Limited
Oct 16, 2024
IVD Test Reagent/Kits, Immunoassay, Protein, Immunoglobulin A
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€่›‹็™ฝ่ดจใ€ๅ…็–ซ็ƒ่›‹็™ฝA
B
Roche Diagnostics (Hong Kong) Limited
Oct 16, 2024
IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Immunosuppressant, Tacrolimus
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซๆต‹ๅฎš, ๆฒป็–—่ฏ็‰ฉ, ๅ…็–ซๆŠ‘ๅˆถๅ‰‚, ไป–ๅ…‹่Žซๅธ
C
Roche Diagnostics (Hong Kong) Limited
Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Pregnancy Hormone, Human Chorionic Gonadotropin
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€ๅฆŠๅจ ๆฟ€็ด ใ€ไบบ็ป’ๆฏ›่†œไฟƒๆ€ง่…บๆฟ€็ด 
B
Roche Diagnostics (Hong Kong) Limited
Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Vitamin, Folate
ไฝ“ๅค–่ฏŠๆ–ญ ๆต‹่ฏ•่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’ใ€ๅ…็–ซๆต‹ๅฎšใ€็ปด็”Ÿ็ด ใ€ๅถ้…ธ
B
Roche Diagnostics (Hong Kong) Limited
Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Fertility Hormone, Androstenedione
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซๆต‹ๅฎš, ็”Ÿ่‚ฒๆฟ€็ด , ้›„็ƒฏไบŒ้…ฎ
B
Roche Diagnostics (Hong Kong) Limited
Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Endocrine, Insulin-Like Growth Factor Binding Protein 3
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซๆต‹ๅฎš, ๅ†…ๅˆ†ๆณŒ, ่ƒฐๅฒ›็ด ๆ ท็”Ÿ้•ฟๅ› ๅญ็ป“ๅˆ่›‹็™ฝ 3
B
Roche Diagnostics (Hong Kong) Limited
Sep 24, 2024
IVD Test Reagent/Kits, Immunocytochemistry/Immunohistochemistry, Tumor Marker, PD-L1
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซ็ป†่ƒžๅŒ–ๅญฆ/ๅ…็–ซ็ป„ๅŒ–, ่‚ฟ็˜คๆ ‡ๅฟ—็‰ฉ, PD-L1
C
Roche Diagnostics (Hong Kong) Limited
Sep 24, 2024
IVD Test Reagent/Kits, Immunoassay, Therapeutic Drug, Anticonvulsant, Valproic Acid
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ๅ…็–ซๆต‹ๅฎš, ๆฒป็–—่ฏ็‰ฉ, ๆŠ—ๆƒŠๅŽฅ่ฏ, ไธ™ๆˆŠ้…ธ
C
Roche Diagnostics (Hong Kong) Limited
Sep 24, 2024
IVD Test Reagent/Kits, Clinical Chemistry, Protein, Total, Cerebrospinal Fluid
ไฝ“ๅค–่ฏŠๆ–ญๆฃ€ๆต‹่ฏ•ๅ‰‚/่ฏ•ๅ‰‚็›’, ไธดๅบŠๅŒ–ๅญฆ, ๆ€ป่›‹็™ฝ่ดจ, ่„‘่„Šๆถฒ
B
Roche Diagnostics (Hong Kong) Limited
Sep 24, 2024
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Risk Class Breakdown
D11
B78
C47
II7
Timeline
First Registration
Dec 11, 2007
Most Recent
Oct 16, 2024