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270 device results listed.

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SAA (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
Manufacturer SRN: CN-MF-000005925
UDI-DI: 06926802604380
Basic UDI-DI: B-06926802604380
Reference: MC L03501E
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Netherlands
Authorised representative: R Sight B.V.
Last updated: 03.08.2026 11:06

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x50mL, R2: 1x10mL

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593573
Basic UDI-DI: B-06925794593573
Reference: 3021557
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x50mL, R2: 1x10mL，Calibration sample:1x1mL, Control:2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794593566
Basic UDI-DI: B-06925794593566
Reference: 3021691
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:50

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Detection Kit (Chemiluminescence Immunoassay)

1×100 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794524102
Basic UDI-DI: B-06925794524102
Reference: 3014679
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:38

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Control Set, CCP

CCP, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030404512
Basic UDI-DI: B-06924030404512
Reference: MY00336
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:04

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Calibrator Set, CCP

CCP, 2 x 1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030403492
Basic UDI-DI: B-06924030403492
Reference: MY00234
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 09:01

Manufacturer products Authorised representative products Authorised representative actors View details

BioCLIA Autoimmune Reagent Kit, CCP

CCP, 100 Tests/Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: HOB Biotech Group Corp., Ltd.
Manufacturer SRN: CN-MF-000023974
UDI-DI: 06924030402983
Basic UDI-DI: B-06924030402983
Reference: MY00183
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Emergo Europe B.V.
Last updated: 03.08.2026 08:59

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Calibrator

IVD Class BIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen CoooSeee Biomedical Co., Ltd.
Manufacturer SRN: CN-MF-000045646
UDI-DI: 06978066778512
Basic UDI-DI: 697806677PR007QU
Reference: 7090-PA00002
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:52

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent (Immunonephelometric Method)

IVD Class CNot specifiedOn the marketDirect marking

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493098942
Basic UDI-DI: 697049309W01023007042CP
Reference: XQ-0010-01
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A Protein Reagent(Immunonephelometric Method)

R 1×13mL

IVD Class CIVDR 2017/746On the marketAnimal tissuesDirect markingHuman tissuesProfessional testingReagent

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06970493097051
Basic UDI-DI: 6970493090506004NX
Reference: MY-0004-01
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:20

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (eCLIA)

50T，2×50T，100T，2×100T

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Lifotronic Technology Co., Ltd.
Manufacturer SRN: CN-MF-000005654
UDI-DI: 06975984063515
Basic UDI-DI: 69703416803205023J7
Reference: 0320502001
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 21:14

Manufacturer products Authorised representative products Authorised representative actors View details

Serum Amyloid A (SAA) Kit (Latex Particle-Enhanced Immunonephelometry Method)

105-020880-00、105-020881-00

IVD Class CIVDR 2017/746On the marketKitProfessional testingReagent

Manufacturer: Shenzhen Mindray Bio-Medical Electronics Co., Ltd.
Manufacturer SRN: CN-MF-000014156
UDI-DI: 06903053029100
Basic UDI-DI: 69449040007C-SAAS-1****MA
Reference: 105-020881-00
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 19:48

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-RF IgM

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717898
Basic UDI-DI: 692591270074HE
Reference: C89036M
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-RF IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717881
Basic UDI-DI: 692591270073HC
Reference: C89035G
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-RA33 IgG

IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912717874
Basic UDI-DI: 692591270069HM
Reference: C89026G
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 31.07.2026 18:31

Manufacturer products Authorised representative products Authorised representative actors View details

IL-6

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147180966
Basic UDI-DI: B-86060147180966
Reference: N1203IL6
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 30.07.2026 02:29

Manufacturer products Authorised representative products Authorised representative actors View details

Cromatest

SLE-Latex

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873213004
Basic UDI-DI: B-84352873213004
Reference: 2430005
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:25

Manufacturer products View details

Heparin-binding protein (HBP) Detection Kit (Nephelometry)

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: 06950334819547
Basic UDI-DI: B-06950334819547
Reference: 32027176
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 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