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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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665 device results listed.

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Immunoglobulin A (IgA) Detection Kit (Nephelometry)

Immunoglobulin A (IgA) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819660
Basic UDI-DI: B-06950334819660
Reference: 32027186
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.06.2026 07:42

Manufacturer products Authorised representative products Authorised representative actors View details

25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334803973
Basic UDI-DI: B-06950334803973
Reference: 32026011
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Cyprus
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334803928
Basic UDI-DI: B-06950334803928
Reference: 32026014
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Cyprus
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

Immunoglobulin A (IgA) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334803874
Basic UDI-DI: B-06950334803874
Reference: 32026010
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Cyprus
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:39

Manufacturer products Authorised representative products Authorised representative actors View details

2*25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334802280
Basic UDI-DI: B-06950334802280
Reference: 32080014
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Cyprus
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:37

Manufacturer products Authorised representative products Authorised representative actors View details

2*25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334802273
Basic UDI-DI: B-06950334802273
Reference: 32080011
EMDN: W0102010107
EMDN description: IMMUNOGLOBULIN M
First on market country: Cyprus
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:37

Manufacturer products Authorised representative products Authorised representative actors View details

2*25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334802266
Basic UDI-DI: B-06950334802266
Reference: 32080010
EMDN: W0102010101
EMDN description: IMMUNOGLOBULIN A
First on market country: Cyprus
Authorised representative: Lotus NL B.V.
Last updated: 28.06.2026 07:37

Manufacturer products Authorised representative products Authorised representative actors View details

N Antisera to Human IgG

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768009792
Basic UDI-DI: 0405686900179VF
Reference: 10446298
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 22:55

Manufacturer products View details

N Latex FLC kappa

-

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00630414312453
Basic UDI-DI: 0405686902230V4
Reference: 10873770
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: -
Authorised representative: -
Last updated: 26.06.2026 22:55

Manufacturer products View details

Lambda Light Chain Reagent Kit（Immunoturbidimetric Assay）

R1: 1x45mL, R2: 1x15mL,

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200182
Basic UDI-DI: B-06942202200182
Reference: 3015825
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200175
Basic UDI-DI: B-06942202200175
Reference: 3015896
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200168
Basic UDI-DI: B-06942202200168
Reference: 3015861
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200151
Basic UDI-DI: B-06942202200151
Reference: 3016072
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200144
Basic UDI-DI: B-06942202200144
Reference: 3015970
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200137
Basic UDI-DI: B-06942202200137
Reference: 3015856
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200120
Basic UDI-DI: B-06942202200120
Reference: 3015816
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

Kappa Light Chain Reagent Kit (Immunoturbidimetric Assay)

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL,

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200113
Basic UDI-DI: B-06942202200113
Reference: 3015855
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1x45mL, R2: 1x15mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200106
Basic UDI-DI: B-06942202200106
Reference: 3016044
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

R1: 1x45mL, R2: 1x15mL, Calibration sample: 1x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202200090
Basic UDI-DI: B-06942202200090
Reference: 3015815
EMDN: W0102010109
EMDN description: KAPPA AND LAMBDA CHAIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 26.06.2026 14:49

Manufacturer products Authorised representative products Authorised representative actors View details

IgG4 Assay Kit (Chemiluminescent Immunoassay)

2×50 tests/box Calibrator: 0.5mL×2; Quality control: 1.0mL×2

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Sichuan Orienter Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000003026
UDI-DI: 06942028501760
Basic UDI-DI: B-06942028501760
Reference: DB2101
EMDN: W0102010105
EMDN description: IMMUNOGLOBULIN G
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 26.06.2026 03:16

Manufacturer products Authorised representative products Authorised representative actors View details