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EUDAMED Device Search

A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.

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Alanine Aminotransferase (ALT) Assay Kit (Enzymatic Kinetic Method)

Alanine Aminotransferase (ALT) Assay Kit (Enzymatic Kinetic Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-52H240T8B
Basic UDI-DI: B-52H240T8B
Reference: 52H240T
EMDN: W01010103
EMDN description: ALANINE AMINO-TRANSFERASE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 02:37

Manufacturer products Authorised representative products Authorised representative actors View details

Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method)

Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-51H60TV8
Basic UDI-DI: B-51H60TV8
Reference: 51H60T
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 02:36

Manufacturer products Authorised representative products Authorised representative actors View details

Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method)

Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-51H60TSCS4
Basic UDI-DI: B-51H60TSCS4
Reference: 51H60TSC
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 02:36

Manufacturer products Authorised representative products Authorised representative actors View details

Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method)

Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-51H240TSC78
Basic UDI-DI: B-51H240TSC78
Reference: 51H240TSC
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 02:35

Manufacturer products Authorised representative products Authorised representative actors View details

Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method)

Alkaline Phosphatase (ALP) Assay Kit (Continuous Monitoring Method)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: YHLO BIOTECH (NANJING) CO., LTD.
Manufacturer SRN: CN-MF-000050474
UDI-DI: D-51H240T7W
Basic UDI-DI: B-51H240T7W
Reference: 51H240T
EMDN: W01010105
EMDN description: ALKALINE PHOSPHATASE - TOTAL
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 02:35

Manufacturer products Authorised representative products Authorised representative actors View details

5'-Nucleotidase Reagent Kit

5'-Nucleotidase Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-5-NT601DR
Basic UDI-DI: B-5-NT601DR
Reference: 5-NT6011Y, 5-NT6012Y, 5-NT6013Y, 5-NT6014Y, 5-NT6015Y, 5-NT6011N, 5-NT6012N, 5-NT6013N, 5-NT6014N, 5-NT6015N
EMDN: W01010101
EMDN description: 5'-NUCLEOTIDASE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 17.07.2026 02:15

Manufacturer products Authorised representative products Authorised representative actors View details

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IVD generalNot specifiedOn the marketSingle use

Manufacturer: Xiamen BioRay Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045502
UDI-DI: 06977194142547
Basic UDI-DI: B-06977194142547
Reference: HR0528002
EMDN: W0102160999
EMDN description: INDIVIDUAL AND SPECIFIC HORMONES/PROTEINS RT & POC - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 19:36

Manufacturer products Authorised representative products Authorised representative actors View details

Urinary Tract Infection (UTI) &DR Panel (Fluorescence PCR method)

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: BioTeke Corporation（Wuxi）Co., Ltd
Manufacturer SRN: CN-MF-000007517
UDI-DI: 06974541565493
Basic UDI-DI: B-06974541565493
Reference: PR2024-UT01
EMDN: W0105010111
EMDN description: CHLAMYDIA TRACHOMATIS ANTIBODY IGM
First on market country: Bulgaria
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 19:12

Manufacturer products Authorised representative products Authorised representative actors View details

Human Telomere Length Real Time PCR Detection Kit

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476393
Basic UDI-DI: B-06970895476393
Reference: TP060104T2024
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Czechia
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

Kit de detección por PCR en tiempo real de la longitud de los telómeros humanos

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: Jiangsu Mole Bioscience Co., LTD.
Manufacturer SRN: CN-MF-000001539
UDI-DI: 06970895476256
Basic UDI-DI: B-06970895476256
Reference: TP060104T2024
EMDN: W010699
EMDN description: GENETIC TESTS - OTHER
First on market country: Czechia
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 19:03

Manufacturer products Authorised representative products Authorised representative actors View details

HCG Pregnancy Test (Urine/Serum/Plasma) (ColloidalGold)

Cassette

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: ANHUI DEEPBLUE MEDICAL TECHNOLOGY CO.,LTD
Manufacturer SRN: CN-MF-000018785
UDI-DI: 06952062771524
Basic UDI-DI: B-06952062771524
Reference: HCG USP
EMDN: W0102050205
EMDN description: TOTAL HUMAN CHORIONIC GONADOTROPIN
First on market country: Germany
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 18:56

Manufacturer products Authorised representative products Authorised representative actors View details

Auto-Pure 10B

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975891208
Basic UDI-DI: 88099758902007000488
Reference: Auto-Pure 10B
EMDN: W02069099
EMDN description: VARIOUS SAMPLE PROCESSING INSTRUMENTS - OTHER
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

HysenD30H

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975891017
Basic UDI-DI: 88099758902007000284
Reference: HysenD30H
EMDN: W02050116
EMDN description: NUCLEIC ACID TESTING INTEGRETED EXTRATION /AMPLIFICATION /DETECTION SYSTEMS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

HysenDx 200

IVD Class AIVDR 2017/746On the marketInstrumentProfessional testing

Manufacturer: Hysen Biotech.Inc
Manufacturer SRN: KR-MF-000048224
UDI-DI: 08809975890034
Basic UDI-DI: 88099758902007000182
Reference: HysenDx 200
EMDN: W02050301
EMDN description: NUCLEIC ACID TESTING APPARATUSES - RAPID AND POINT OF CARE TESTS
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 12:51

Manufacturer products Authorised representative products Authorised representative actors View details

Trastuzumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class CIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293591503
Basic UDI-DI: 697518250F114392P
Reference: F11439-50
EMDN: W01020899
EMDN description: THERAPEUTIC DRUG MONITORING - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Free Anti-Rituximab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552269
Basic UDI-DI: 697518250P1146972
Reference: F11447-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-vedolizumab CLIA Kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552160
Basic UDI-DI: 697518250F114522F
Reference: F11452-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Rituximab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552153
Basic UDI-DI: 697518250F114342D
Reference: F11434-50
EMDN: W0102080704
EMDN description: RITUXIMAB
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Free Anti-Ustekinumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552122
Basic UDI-DI: 697518250F114332B
Reference: F11433-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details

Ustekinumab CLIA kit (Chemiluminescence Immunoassay)

100 tests/box

IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent

Manufacturer: Beijing Diagreat Biotechnologies Co., Ltd.
Manufacturer SRN: CN-MF-000019511
UDI-DI: 06942293552115
Basic UDI-DI: 697518250F1143229
Reference: F11432-50
EMDN: W0102080799
EMDN description: AUTOIMMUNE DISEASE TDM - OTHER
First on market country: Italy
Authorised representative: Medunion S.L.
Last updated: 16.07.2026 11:07

Manufacturer products Authorised representative products Authorised representative actors View details