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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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01.08.2026 18:27

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332 device results listed.

Page 14 / 17

Nephstar RF Kit

Nephstar RF Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225933562
Basic UDI-DI: B-06971225933562
Reference: DK023
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:26

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo RF Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930691
Basic UDI-DI: B-06971225930691
Reference: OP23100
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

Omlipo RF Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930684
Basic UDI-DI: B-06971225930684
Reference: OP23050
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:22

Manufacturer products Authorised representative products Authorised representative actors View details

GPP-100 RF Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Goldsite Diagnostics Inc.
Manufacturer SRN: CN-MF-000001353
UDI-DI: 06971225930387
Basic UDI-DI: B-06971225930387
Reference: GP23020
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 06.07.2026 12:21

Manufacturer products Authorised representative products Authorised representative actors View details

22162

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100844
Basic UDI-DI: B-05404035100844
Reference: 22162
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Belgium
Authorised representative: -
Last updated: 06.07.2026 08:31

Manufacturer products View details

Atlas RF Latex Kit, 125 Tests (5 ml Latex, 2x1 ml controls, Glass slide, Stirring sticks).

8.00.04.3.0125

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Atlas Medical GmbH
Manufacturer SRN: DE-MF-000029961
UDI-DI: 04260658557943
Basic UDI-DI: B-04260658557943
Reference: 8.00.04.3.0125
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 07:53

Manufacturer products View details

Rheumatoid Factor Kit (Particle-enhanced Immunoturbidimetric Assay Method)

-

IVD Class BNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037424
Basic UDI-DI: 69449040004GRF*********PB
Reference: 105-002161-00
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor Kit (Particle-enhanced Immunoturbidimetric Assay Method)

-

IVD Class BNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037547
Basic UDI-DI: 69449040004GRF*********PB
Reference: 105-002177-00
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor Kit (Particle-enhanced Immunoturbidimetric Assay Method)

-

IVD Class BNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037561
Basic UDI-DI: 69449040004GRF*********PB
Reference: 105-002179-00
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

-

IVD Class BNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904037813
Basic UDI-DI: 69449040004GRF*********PB
Reference: 105-003683-00
EMDN: W01021110
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor Kit (Immunoturbidimetric Method)

-

IVD Class BNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904053554
Basic UDI-DI: 69449040004MRF*********W9
Reference: 105-004633-00
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor Kit (Immunoturbidimetric Method)

-

IVD Class BNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904053561
Basic UDI-DI: 69449040004MRF*********W9
Reference: 105-004634-00
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor Calibrator

-

IVD Class BNot specifiedOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06944904053677
Basic UDI-DI: 69449040004MRF*********W9
Reference: 105-004645-00
EMDN: W01021110
EMDN description: STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 06.07.2026 05:10

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor IgA/IgG/IgM ELISA

Rheumatoid Factor IgA/IgG/IgM ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: IBL International GmbH
Manufacturer SRN: DE-MF-000015709
UDI-DI: 04049325003897
Basic UDI-DI: B-04049325003897
Reference: RE70341
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:09

Manufacturer products View details

Rheumatoid Factor IgA ELISA

IVD generalIVDDOn the marketKitProfessional testing

Manufacturer: Demeditec Diagnostics GmbH
Manufacturer SRN: DE-MF-000012836
UDI-DI: 04049198014235
Basic UDI-DI: B-04049198014235
Reference: DE7630
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 06.07.2026 03:07

Manufacturer products View details

ABX Pentra RF CP

A11A01613

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004814
Basic UDI-DI: B-03610230004814
Reference: A11A01613
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: France
Authorised representative: -
Last updated: 05.07.2026 16:59

Manufacturer products View details

C-Reactive Protein/Anti-streptolysin O/Rheumatoid Factor Reagent Kit

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Changsha Sinocare Inc.
Manufacturer SRN: CN-MF-000012244
UDI-DI: D-02B0029YZ
Basic UDI-DI: B-02B0029YZ
Reference: 2U001
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: Lotus NL B.V.
Last updated: 05.07.2026 16:29

Manufacturer products Authorised representative products Authorised representative actors View details

EasyMagPlex Rheumatoid Arthritis IgM Kit

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Wellgrow Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000045201
UDI-DI: D-0136D
Basic UDI-DI: B-0136D
Reference: 341401HNE,341402HNE,341403HNE,341404HNE,341405HNE,341406HNE
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 05.07.2026 16:09

Manufacturer products Authorised representative products Authorised representative actors View details

50T/Kit, 50T/Kit(W Control), 100T/Kit, 100T/Kit (W Control), 48T/Kit, 48T/Kit(W Control)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Hunan Wellgrow Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000045201
UDI-DI: D-0126B
Basic UDI-DI: B-0126B
Reference: 341501HNE,341502HNE,341503HNE,341504HNE,341505HNE,341506HNE
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Austria
Authorised representative: JOYSUN GROUP S.L.U
Last updated: 05.07.2026 16:09

Manufacturer products Authorised representative products Authorised representative actors View details

K-ASSAY RF (Ver.2)

RF (Ver.2) Reagent

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021457
Basic UDI-DI: B-00816426021457
Reference: KAI-230
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 04.07.2026 21:39

Manufacturer products Authorised representative products Authorised representative actors View details