18 results
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17ms
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Sources: EU EUDAMED, US FDA
Filters
Regulation: Eu Ivdr
×
LIH
Device
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Inc.·On the market
LIH
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Beckman Coulter Inc.·1 device
DEVICES FOR ADMINISTRATION, WITHDRAWAL AND COLLECTION - OTHER
Device
EU IVDR
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Eu Ivd Class A
·Hangzhou Laihe Biotech Co., Ltd.·On the market·0 countries
GONOCOCCAL ANTIGEN DETECTION
Device
EU IVDR
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Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country
STIS / STDS (C.TRACHOMATIS, N.GONORRHOEAE ,M.GENITALIUM, T.VAGINALIS, UREAPLASMA SPP….) COMBINATION - MULTIPLEX NA REAGENTS [extension of the scope as of 2025-01-01]
Device
EU IVDR
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Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·On the market·1 country
Chlamydia Antigen Rapid Test Kit
Device
EU IVDR
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Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·On the market·3 countries
LDH
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Beckman Coulter Ireland Inc.·1 device
LDH
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Beckman Coulter Ireland Inc.·1 device
LDH (IFCC)
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Thermo Fisher Scientific Oy·1 device
LDH P-L
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Medicon Hellas SA·2 devices
LDH L-P
Basic UDI-DI
EU IVDR
·
Eu Ivd Class B
·Medicon Hellas SA·5 devices
Incubator
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·Changsha Yingtai Instrument Co., Ltd·1 device
BIOSYNEX FLACON URINE URITOP +2
Basic UDI-DI
EU IVDR
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Eu Ivd Class A
·Hangzhou Laihe Biotech Co., Ltd.·1 device
Gonorrhea Antigen Rapid Test Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·1 device
Chlamydia and Gonorrhea Antigen Rapid Test Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·1 device
Chlamydia Antigen Rapid Test Kit
Basic UDI-DI
EU IVDR
·
Eu Ivd Class C
·Hangzhou Laihe Biotech Co., Ltd.·1 device
HYDRASYS ISO-LDH, ISO-PAL, CHOL ACCESSORIES
Basic UDI-DI
EU IVDR
·
Eu Ivd Class A
·sebia·1 device
Luteinizing Hormone（CLIA）、LH Calibrators
Basic UDI-DI
EU IVDR
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Eu Ivd Class B
·Shenzhen Mindray Bio-Medical Electronics Co., Ltd.·3 devices