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AESKULISA® Rf-AGM

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500777
Basic UDI-DI: B-04250289500777
Reference: 3161
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® Rf-Check

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500760
Basic UDI-DI: B-04250289500760
Reference: 3160
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

AESKULISA® Sclero-Pro

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingSingle use

Manufacturer: Aesku.Diagnostics GmbH & Co. KG
Manufacturer SRN: DE-MF-000026925
UDI-DI: 04250289500609
Basic UDI-DI: B-04250289500609
Reference: 3121
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Germany
Authorised representative: -
Last updated: 05.08.2026 08:57

Manufacturer products View details

Anti-cyclic Citrullinated Peptide Antibodies Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x45ml, R2: 1x15ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238079
Basic UDI-DI: B-06942202238079
Reference: 3011468
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cyclic Citrullinated Peptide Antibodies Reagent Kit (Latex Immunoturbidimetric Assay)

R1: 1x45ml, R2: 1x15ml, Calibration sample: 2x1mL, Control: 2x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238086
Basic UDI-DI: B-06942202238086
Reference: 3011799
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

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: 06942202239489
Basic UDI-DI: B-06942202239489
Reference: 3011837
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

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: 06942202239458
Basic UDI-DI: B-06942202239458
Reference: 3011415
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

ANTI-STREPTOLYSIN O KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40ml, R2: 1x10ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketKitMicrobial substancesProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202238703
Basic UDI-DI: B-06942202238703
Reference: 3014556
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 2x60ml, R2: 2x15ml

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202240997
Basic UDI-DI: B-06942202240997
Reference: 3012486
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 2x60ml, R2: 2x15ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239687
Basic UDI-DI: B-06942202239687
Reference: 3014557
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 05.08.2026 06:45

Manufacturer products Authorised representative products Authorised representative actors View details

CRP LATEX

LXCR-0112

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700829379
Basic UDI-DI: B-03701700829379
Reference: LXCR-0112
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details

ANTI-STREPTOLYSIN O

ASLO-4001

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700801238
Basic UDI-DI: B-03701700801238
Reference: ASLO-4001
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details

ANTI-STREPTOLYSIN O

ASLO-6006

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700801221
Basic UDI-DI: B-03701700801221
Reference: ASLO-6006
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details

ANTI-STREPTOLYSIN O

ASLO-5025

IVD generalIVDDOn the marketProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700801214
Basic UDI-DI: B-03701700801214
Reference: ASLO-5025
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details

ANTI-STREPTOLYSIN O

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: VitalScientific
Manufacturer SRN: FR-MF-000004722
UDI-DI: 03701700801207
Basic UDI-DI: B-03701700801207
Reference: ASLO-0250
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: France
Authorised representative: -
Last updated: 05.08.2026 02:59

Manufacturer products View details

K-ASSAY RF Calibrator (Ver.2)

RF Calibrator (Ver.2)

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: KAMIYA BIOMEDICAL COMPANY, LLC
Manufacturer SRN: US-MF-000002769
UDI-DI: 00816426021464
Basic UDI-DI: B-00816426021464
Reference: KAI-231C
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Czechia
Authorised representative: Advena Limited
Last updated: 05.08.2026 01:15

Manufacturer products Authorised representative products Authorised representative actors View details

C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40ml, R2: 1x10ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794588982
Basic UDI-DI: B-06925794588982
Reference: 3004827
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

C-REACTIVE PROTEIN REAGENT KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 2x60ml, R2: 2x15ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06925794588968
Basic UDI-DI: B-06925794588968
Reference: 3004628
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

RHEUMATOID FACTOR KIT（LATEX ENHANCED IMMUNOTURBIDIMETRIC ASSAY）

R1: 1x40ml, R2: 1x10ml, Calibration sample: 1x1mL

IVD generalIVDDOn the marketHuman tissuesKitProfessional testingReagent

Manufacturer: DIRUI INDUSTRIAL CO., LTD
Manufacturer SRN: CN-MF-000001891
UDI-DI: 06942202239816
Basic UDI-DI: B-06942202239816
Reference: 3004621
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Austria
Authorised representative: Emergo Europe B.V.
Last updated: 04.08.2026 22:53

Manufacturer products Authorised representative products Authorised representative actors View details

RF IgM CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359544382
Basic UDI-DI: 697015090000302H3
Reference: CMQ1105
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 04.08.2026 22:13

Manufacturer products Authorised representative products Authorised representative actors View details