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Dimension CardioPhase high sensitivity CRP Flex reagent cartridge

IVDR_67_GLA_DUB-C_C_REAG_CCRP

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

Manufacturer: Siemens Healthcare Diagnostics Inc.
Manufacturer SRN: US-MF-000016336
UDI-DI: 00842768016028
Basic UDI-DI: 0405686901077VD
Reference: 10444897
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:29

Manufacturer products Authorised representative products Authorised representative actors View details

IMMULITE 2000 Anti-CCP IgG

IVDR_67_LLB_DUB-C_B_REAG_KIT_Anti-CCP IgG

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

Manufacturer: Siemens Healthcare Diagnostics Products Ltd.
Manufacturer SRN: GB-MF-000016339
UDI-DI: 00630414982151
Basic UDI-DI: 0405686901368VT
Reference: 10368607
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: Siemens Healthcare Diagnostics Manufacturing Limited
Last updated: 16.07.2026 00:27

Manufacturer products Authorised representative products Authorised representative actors View details

N Latex ADNase B

IVDR_27_MAR EB_B_KIT_N_La_ADN_B

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768013317
Basic UDI-DI: 0405686900957WD
Reference: 10446658
EMDN: W01021101
EMDN description: ANTI-STREPTOCOCCAL DEOXYRIBONUCLEASE B (ANTI-DNAASE B)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:20

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N Latex SAA

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

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N Latex RF Kit

IVDR_27_MAR EB_B_KIT_N_La_RF

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006883
Basic UDI-DI: 0405686900886WF
Reference: 10445991
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

Manufacturer products View details

N Latex ASL

IVDR_27_MAR EB_B_REAG_N_La_ASL

IVD Class BIVDR 2017/746On the marketHuman tissuesMicrobial substancesProfessional testingReagent

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006791
Basic UDI-DI: 0405686900878WG
Reference: 10445983
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:19

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Dimension Vista Rheumatoid Factors Flex reagent cartridge

IVDR_67_MAR EB_B_KIT_V_RF

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006234
Basic UDI-DI: 0405686900928W6
Reference: 10445908
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:18

Manufacturer products View details

Dimension Vista C-Reactive Protein Flex reagent cartridge

IVDR_67_MAR EB_C_KIT_V_CRP

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

Manufacturer: Siemens Healthcare Diagnostics Products GmbH
Manufacturer SRN: DE-MF-000005039
UDI-DI: 00842768006081
Basic UDI-DI: 0405686900912VP
Reference: 10445893
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: -
Last updated: 16.07.2026 00:18

Manufacturer products View details

hs-CRP High-sensitivity C-reactive Protein (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-hs-CRP706-AEUC
Basic UDI-DI: B-hs-CRP706-AEUC
Reference: hs-CRP706-AE10Y, hs-CRP706-AE10N, hs-CRP706-AE20Y, hs-CRP706-AE20N
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 14:19

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cyclic Citrullinated Peptide Antibody Test Kit (FIA)

VID119

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: VivaChek Biotech (Hangzhou) Co., Ltd.
Manufacturer SRN: CN-MF-000012160
UDI-DI: D-VID119F2
Basic UDI-DI: B-VID119F2
Reference: VID119-01-011
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Italy
Authorised representative: Lotus NL B.V.
Last updated: 15.07.2026 13:20

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-704A

Anti-cyclic Citrullinated Peptide Antibody Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-704A
Basic UDI-DI: B-TD-HNKX-CED-704A
Reference: /
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors View details

D-TD-HNKX-CED-694R

Rheumatoid Factor Kit (Microfluidic Fluorescent Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Hunan Kangxin Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000020121
UDI-DI: D-TD-HNKX-CED-694R
Basic UDI-DI: B-TD-HNKX-CED-694R
Reference: /
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 10:57

Manufacturer products Authorised representative products Authorised representative actors 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-1746

C-Reactive Protein 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-1746
Basic UDI-DI: B-TD-HNKX-CED-1746
Reference: /
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
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

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

Rheumatoid Factor (RA)

IVD generalIVDDNo longer on the marketKitProfessional testingReagent

Manufacturer: NS BIOTEC
Manufacturer SRN: EG-MF-000032515
UDI-DI: D-RheumatoidFactor3Z
Basic UDI-DI: B-RheumatoidFactor3Z
Reference: Ra-Ma-050
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: -
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 15.07.2026 05:33

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

Rheumatoid Factor Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-RF601WC
Basic UDI-DI: B-RF601WC
Reference: RF6011Y, RF6012Y, RF6013Y, RF6014Y, RF6015Y, RF6011N, RF6012N, RF6013N, RF6014N, RF6015N
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 15.07.2026 05:27

Manufacturer products Authorised representative products Authorised representative actors View details

C-Reactive Protein (CRP) Detection Kit (Nephelometry)

25 tests

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Genrui Biotech Inc.
Manufacturer SRN: CN-MF-000017351
UDI-DI: D-PA000455
Basic UDI-DI: B-PA000455
Reference: 32026009
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: Lotus NL B.V.
Last updated: 14.07.2026 06:32

Manufacturer products Authorised representative products Authorised representative actors View details