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RF LATEX R1:1x40ml, R2:1x10ml

IVD generalIVDDOn the marketKitProfessional testingReagent

Manufacturer: Biotechnological Applications Ltd
Manufacturer SRN: GR-MF-000033000
UDI-DI: 05213003190875
Basic UDI-DI: B-05213003190875
Reference: 001219
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:51

Manufacturer products View details

DyonCRP

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: DYONMED SA
Manufacturer SRN: GR-MF-000033588
UDI-DI: 05200251200401
Basic UDI-DI: B-05200251200401
Reference: DNDL101
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Greece
Authorised representative: -
Last updated: 02.08.2026 18:47

Manufacturer products View details

Anti-CCP

IVD generalNot specifiedOn the marketSingle use

Manufacturer: GA Generic Assays GmbH
Manufacturer SRN: DE-MF-000032990
UDI-DI: 04250310703962
Basic UDI-DI: B-04250310703962
Reference: 3665
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: -
Last updated: 01.08.2026 13:58

Manufacturer products 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

C-Reactive Protein Reagent (Immunonephelometric Method)

R ：1×13mL （75mm×45mm×105mm）

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

Manufacturer: Shenzhen Dymind Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000024842
UDI-DI: 06976117454118
Basic UDI-DI: 6970493090506007P5
Reference: MY-0001-02
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: Eunitor GmbH
Last updated: 31.07.2026 21:22

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

Anti-Cyclic Citrullinated Peptide Antibody test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700408973
Basic UDI-DI: 697029753454LV
Reference: HGCL93
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:09

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-cyclic Citrullinated Peptide Antibody rapid test (Colloidal Gold)

Please see the IFU

IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403442
Basic UDI-DI: 697029753312L8
Reference: HGCG02
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

C reactive protein test (Up-converting Phosphor Technology)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403343
Basic UDI-DI: 697029753306LD
Reference: HGUPT01
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:08

Manufacturer products Authorised representative products Authorised representative actors View details

C-reactive protein test (Chemiluminescence Immunoassay)

Please see the IFU

IVD Class CIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Beijing Hotgen Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000015566
UDI-DI: 06936700403145
Basic UDI-DI: 697029753044L6
Reference: HGCL09
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Germany
Authorised representative: MedNet EC-REP GmbH
Last updated: 31.07.2026 21:07

Manufacturer products Authorised representative products Authorised representative actors View details

RF IgA 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: 06942359544580
Basic UDI-DI: 697015090000304H7
Reference: CMQ1305
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:03

Manufacturer products Authorised representative products Authorised representative actors View details

RF IgG 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: 06942359544481
Basic UDI-DI: 697015090000303H5
Reference: CMQ1205
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:02

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: 06942359544368
Basic UDI-DI: 697015090000302H3
Reference: CMQ1103
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

RF 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: 06942359544283
Basic UDI-DI: 697015090000301GZ
Reference: CMQ1005
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP IgG 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: 06942359515689
Basic UDI-DI: 697015090000116H4
Reference: CMQ1410
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 21:02

Manufacturer products Authorised representative products Authorised representative actors View details

hs-CRP CLIA Microparticles

AutoLumo analyzer

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

Manufacturer: Autobio Diagnostics Co., Ltd.
Manufacturer SRN: CN-MF-000003348
UDI-DI: 06942359547598
Basic UDI-DI: 697015090000042GY
Reference: CMR0103
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:50

Manufacturer products Authorised representative products Authorised representative actors View details

RF IgA 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: 06942359544566
Basic UDI-DI: 697015090000304H7
Reference: CMQ1303
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details

RF IgG 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: 06942359544467
Basic UDI-DI: 697015090000303H5
Reference: CMQ1203
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: QbD RepS BV
Last updated: 31.07.2026 20:49

Manufacturer products Authorised representative products Authorised representative actors View details