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271 device results listed.

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Serum Amyloid Protein A (SAA) Detection Kit (Nephelometry)

Serum Amyloid Protein A (SAA) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819530
Basic UDI-DI: B-06950334819530
Reference: 32027202
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Türkiye
Authorised representative: Medunion S.L.
Last updated: 28.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

"Serum Amyloid A (SAA) Diagnostic Kit (Immunochromatographic Assay)"

20 Tests/Box

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348760359
Basic UDI-DI: B-06971348760359
Reference: MF-29-20
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Poland
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:52

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Control

Serum Amyloid A (SAA) Control

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778529
Basic UDI-DI: 697806677PR008QW
Reference: 7080-PA00003
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Assay Kit (Latex-enhanced Nephelometry)

Serum Amyloid A (SAA) Assay Kit (Latex-enhanced Nephelometry)

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778475
Basic UDI-DI: 697806677PR006QS
Reference: 7110-ER00001
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 23:00

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Assay Kit (Latex-enhanced Nephelometry)

-

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778482
Basic UDI-DI: 697806677PR006QS
Reference: 7110-ER00002
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Assay Kit (Latex-enhanced Nephelometry)

-

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778499
Basic UDI-DI: 697806677PR006QS
Reference: 7110-ER00003
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Assay Kit (Latex-enhanced Nephelometry)

-

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778505
Basic UDI-DI: 697806677PR006QS
Reference: 7110-ER00004
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Control

-

IVD Class BIVDR 2017/746Not intended for EU marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778536
Basic UDI-DI: 697806677PR008QW
Reference: 7080-PA00004
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: MedNet EC-REP GmbH
Last updated: 23.07.2026 22:39

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Diagnostic Kit (Immunochromatographic Assay)

Serum Amyloid A (SAA) Diagnostic Kit (Immunochromatographic Assay)

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348762674
Basic UDI-DI: 697134876029C267437
Reference: MF-029-20
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Poland
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 23:05

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Diagnostic Kit (Immunochromatographic Assay)

-

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagentSingle use

Manufacturer: Shenzhen Microprofit Biotech Co., Ltd
Manufacturer SRN: CN-MF-000019518
UDI-DI: 06971348764678
Basic UDI-DI: 697134876029C267437
Reference: MF-029-25
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 21.07.2026 22:52

Manufacturer products Authorised representative products Authorised representative actors View details

SAA Rapid Test

IVD generalIVDDNo longer on the marketAnimal tissuesKitNear-patient testingProfessional testingSingle use

Manufacturer: Zhejiang Anji Saianfu Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000045029
UDI-DI: 69743840308518
Basic UDI-DI: B-69743840308518
Reference: 3051401
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: -
Authorised representative: Lotus NL B.V.
Last updated: 17.07.2026 04:11

Manufacturer products Authorised representative products Authorised representative actors View details

Biossays Serum Amyloid A (Latex Immunoturbidimetric)

Serum Amyloid A (Latex Immunoturbidimetric)

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: Shenzhen New Industries Biomedical Engineering Co., Ltd.
Manufacturer SRN: CN-MF-000005655
UDI-DI: 06947145588953
Basic UDI-DI: 69471455642WM
Reference: 130513001S
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Italy
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 16.07.2026 10:43

Manufacturer products Authorised representative products Authorised representative actors View details

IVDR_27_MAR EB_B_KIT_N_La_SAA

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitMicrobial substancesProfessional testing

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768007880
Basic UDI-DI: 0405686900962W6
Reference: 10446108
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

D-TD-HNKX-CED-213V

PCT & IL-6 Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-213V
Basic UDI-DI: B-TD-HNKX-CED-213V
Reference: /
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-203T

CRP & Serum Amyloid A Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-203T
Basic UDI-DI: B-TD-HNKX-CED-203T
Reference: /
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:56

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-1644

Serum Amyloid A Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagentSingle use

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-1644
Basic UDI-DI: B-TD-HNKX-CED-1644
Reference: /
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:55

Manufacturer products Authorised representative products Authorised representative actors View details

RF IgM (CLIA)

IVD generalIVDDOn the marketKitProfessional testingReagentSingle use

Manufacturer: DROPHIL BIOTECH (SHENZHEN) COMPANY LIMITED
Manufacturer SRN: CN-MF-000042193
UDI-DI: D-RFIgM7J
Basic UDI-DI: B-RFIgM7J
Reference: 48 tests/kit: (Excluding calibrators and controls)/(Including calibrators)/(Including calibrators and controls)
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 15.07.2026 05:27

Manufacturer products Authorised representative products Authorised representative actors View details

SAA-BP, SAA-BF

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K91201-074E
Basic UDI-DI: B-K91201-074E
Reference: /
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:38

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Test Kit (Fluorescence Immunochromatographic Assay)

IVD generalIVDDOn the marketAnimal tissuesKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: SHENZHEN REETOO BIOTECHNOLOGY CO., LTD
Manufacturer SRN: CN-MF-000011699
UDI-DI: D-K90411-007PB
Basic UDI-DI: B-K90411-007PB
Reference: /
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Italy
Authorised representative: Umedwings Netherlands B.V.
Last updated: 14.07.2026 03:36

Manufacturer products Authorised representative products Authorised representative actors View details

Serum amyloid A Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4492022LB
Basic UDI-DI: B-IM4492022LB
Reference: IM4492022
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:36

Manufacturer products Authorised representative products Authorised representative actors View details