91 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Eu Ivd Class C
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RIDA®UNITY EHEC/EPEC
Basic UDI-DI
EU IVDR
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Eu Ivd Class C
·R-Biopharm AG·1 device
RIDA®GENE EHEC/EPEC
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·R-Biopharm AG·3 devices
Human Epididymal Protein 4(CLIA) 、HE-4 Calibrators
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
TOTAL PROSTATIC SPECIFIC ANTIGEN
Device
EU IVDR
·
Eu Ivd Class C
·Chemclin Diagnostics Co., Ltd.·On the market·1 country
TOTAL PROSTATIC SPECIFIC ANTIGEN
Device
EU IVDR
·
Eu Ivd Class C
·Chemclin Diagnostics Co., Ltd.·On the market·1 country
TOTAL PROSTATIC SPECIFIC ANTIGEN
Device
EU IVDR
·
Eu Ivd Class C
·Chemclin Diagnostics Co., Ltd.·On the market·1 country
TOTAL PROSTATIC SPECIFIC ANTIGEN
Device
EU IVDR
·
Eu Ivd Class C
·Chemclin Diagnostics Co., Ltd.·On the market·1 country
High sensitive Cardiac Troponin-I test (Chemiluminescence Immunoassay)
Device
EU IVDR
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Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
α-fetoprotein test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
N-terminal Pro-B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Cancer Antigen 125 test (Chemiluminescence Immunoassay)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Cancer Antigen 19-9 test (Chemiluminescence Immunoassay)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Human Epididymis Protein 4 test (Chemiluminescence Immunoassay)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
N-terminal Pro-B-type Natriuretic Peptide rapid test (Colloidal Gold)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Cardiac Troponin-I test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
N-terminal Pro-B-type Natriuretic Peptide test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Procalcitonin test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
C reactive protein test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
B-type Natriuretic Peptide test (Chemiluminescence Immunoassay)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Glycosylated Hemoglobin test (Chemiluminescence Immunoassay)
Device
EU IVDR
·
Eu Ivd Class C
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries