137 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Classification: Eu Ivd Class B
×
Apolipoprotein A1 Kit (Turbidimetry Method)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices
α1-Microglobulin Calibrator Set
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
small dense LDL-Control Set
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
FOLLICLE STIMULATING HORMONE
Device
EU IVDR
·
Eu Ivd Class B
·Chemclin Diagnostics Co., Ltd.·On the market·1 country
FOLLICLE STIMULATING HORMONE
Device
EU IVDR
·
Eu Ivd Class B
·Chemclin Diagnostics Co., Ltd.·On the market·1 country
FOLLICLE STIMULATING HORMONE
Device
EU IVDR
·
Eu Ivd Class B
·Chemclin Diagnostics Co., Ltd.·On the market·1 country
FOLLICLE STIMULATING HORMONE
Device
EU IVDR
·
Eu Ivd Class B
·Chemclin Diagnostics Co., Ltd.·On the market·1 country
small dense LDL-Calibrator
Device
EU IVDR
·
Eu Ivd Class B
·Denka Co., Ltd.·On the market·32 countries
25-hydroxy-vitamin D test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
25-hydroxy-vitamin D test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Anti-cyclic Citrullinated Peptide Antibody Test ((Enzyme-Linked Immunosorbent Assay)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Insulin test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
C-Peptide test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Thyroid-stimulating hormone test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Free Thyroxine test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Total Thyroxine test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Free Triiodothyronine test (Up-converting Phosphor Technology)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
25-hydroxy-vitamin D test (Chemiluminescence Immunoassay)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Anti-Mullerian hormone test (Chemiluminescence Immunoassay)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries
Anti-cyclic Citrullinated Peptide Antibody rapid test (Colloidal Gold)
Device
EU IVDR
·
Eu Ivd Class B
·Beijing Hotgen Biotech Co., Ltd.·On the market·2 countries