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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

CRP ELISA

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: Immundiagnostik AG
Manufacturer SRN: DE-MF-000020905
UDI-DI: 04050598197107
Basic UDI-DI: B-04050598197107
Reference: K 9710s
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: -
Last updated: 31.07.2026 15:25

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CRP Latex

221020

IVD Class BIVDR 2017/746On the marketAnimal tissuesDirect markingKitProfessional testingReagentSingle use

Manufacturer: Cypress Diagnostics
Manufacturer SRN: BE-MF-000000033
UDI-DI: 05404035100264
Basic UDI-DI: 54040351221020BU
Reference: 221020
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Belgium
Authorised representative: -
Last updated: 31.07.2026 10:45

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Optilite® Anti-streptolysin O Kit

LK189.OPT

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

Manufacturer: The Binding Site Group Ltd
Manufacturer SRN: UK-MF-000036707
UDI-DI: 05051700017343
Basic UDI-DI: 5051700LK189.OPT8W
Reference: LK189.OPT
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Germany
Authorised representative: The Binding Site Ireland Limited
Last updated: 31.07.2026 08:05

Manufacturer products Authorised representative products Authorised representative actors View details

Celltac chemi CRP 4N CR-421W

C-REACTIVE PROTEIN

IVD Class BIVDR 2017/746On the marketAnimal tissuesProfessional testingReagentSingle use

Manufacturer: NIHON KOHDEN CORPORATION
Manufacturer SRN: JP-MF-000019022
UDI-DI: 04931921001691
Basic UDI-DI: 4931921IVD0014NU
Reference: CR-421W
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: NIHON KOHDEN EUROPE GmbH
Last updated: 31.07.2026 07:22

Manufacturer products Authorised representative products Authorised representative actors View details

RHEUMATOID FACTOR

IRFA-0230

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

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700823605
Basic UDI-DI: 37017008IRFA009E
Reference: IRFA-0230
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:51

Manufacturer products View details

CRP IP

ICRP-0400

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700822004
Basic UDI-DI: 37017008ICRP0098
Reference: ICRP-0400
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:51

Manufacturer products View details

RHEUMATOID FACTOR

RHFA-M130

IVD Class BIVDR 2017/746On the marketHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700808008
Basic UDI-DI: 37017008RHFA019P
Reference: RHFA-M130
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:50

Manufacturer products View details

CRP IP

ICRP-M230

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700804802
Basic UDI-DI: 37017008ICRP019A
Reference: ICRP-M230
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:49

Manufacturer products View details

Yumizen C560 CRP

1300147999

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009956
Basic UDI-DI: 361023ymz_c560crpMT
Reference: 1300147999
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

Yumizen C CRP

1300147998

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230009949
Basic UDI-DI: 361023ymz_ccrpEY
Reference: 1300147998
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:17

Manufacturer products View details

ABX Pentra CRP CP

A11A01611

IVD Class CIVDR 2017/746On the marketAnimal tissuesProfessional testingReagent

Manufacturer: HORIBA ABX SAS
Manufacturer SRN: FR-MF-000000320
UDI-DI: 03610230004791
Basic UDI-DI: 361023pentra_crpBF
Reference: A11A01611
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: -
Last updated: 30.07.2026 21:14

Manufacturer products View details

IMMAGE Immunochemistry Systems High Sensitivity C-Reactive Protein (CRPH) Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590227005
Basic UDI-DI: 150995901474630LQ
Reference: 474630
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:34

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems CRP C-Reactive Protein Reagent

IVD Class CIVDR 2017/746On the marketAnimal tissuesHuman tissuesProfessional testingReagent

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590231910
Basic UDI-DI: 150995901447280L7
Reference: 447280
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:25

Manufacturer products Authorised representative products Authorised representative actors View details

IMMAGE Immunochemistry Systems RF Rheumatoid Factor Reagent

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

Manufacturer: Beckman Coulter Inc.
Manufacturer SRN: US-MF-000010288
UDI-DI: 15099590226947
Basic UDI-DI: 150995901447070KS
Reference: 447070
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Ireland
Authorised representative: Beckman Coulter Ireland Inc.
Last updated: 30.07.2026 20:24

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

hs CRP

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147156374
Basic UDI-DI: B-86060147156374
Reference: N1605M24HCRP
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
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

Clonatest

RF-Turbidimetric

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Linear Chemicals S.L.U
Manufacturer SRN: ES-MF-000003284
UDI-DI: 84352873311076
Basic UDI-DI: B-84352873311076
Reference: KR31302
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: -
Last updated: 29.07.2026 11:25

Manufacturer products View details