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D-IM4403271J6

RF-IgA Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403271J6
Basic UDI-DI: B-IM4403271J6
Reference: IM4403271
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403270J4

RF-IgM Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403270J4
Basic UDI-DI: B-IM4403270J4
Reference: IM4403270
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403269JK

RF-IgG Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403269JK
Basic UDI-DI: B-IM4403269JK
Reference: IM4403269
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403268JH

RF Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403268JH
Basic UDI-DI: B-IM4403268JH
Reference: IM4403268
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:23

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4403251HY

Anti-CCP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403251HY
Basic UDI-DI: B-IM4403251HY
Reference: IM4403251
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:22

Manufacturer products Authorised representative products Authorised representative actors View details

ILE-MJS02A6

RF-Absorbens

IVD generalIVDDOn the marketAnimal tissuesProfessional testingReagent

Manufacturer: Gold Standard Diagnostics Kassel GmbH
Manufacturer SRN: DE-MF-000021646
UDI-DI: ILE-MJS02A6
Basic UDI-DI: B-ILE-MJS02A6
Reference: ILE-MJS02
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: -
Last updated: 14.07.2026 01:19

Manufacturer products View details

D-IM4403022HF

Serum amyloid A Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4403022HF
Basic UDI-DI: B-IM4403022HF
Reference: IM4403022
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:19

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402271HX

RF-IgA Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402271HX
Basic UDI-DI: B-IM4402271HX
Reference: IM4402271
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402270HV

RF-IgM Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402270HV
Basic UDI-DI: B-IM4402270HV
Reference: IM4402270
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402269JC

RF-IgG Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402269JC
Basic UDI-DI: B-IM4402269JC
Reference: IM4402269
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402268JA

RF Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402268JA
Basic UDI-DI: B-IM4402268JA
Reference: IM4402268
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402251HR

Anti-CCP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402251HR
Basic UDI-DI: B-IM4402251HR
Reference: IM4402251
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:18

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4402022H8

Serum amyloid A Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4402022H8
Basic UDI-DI: B-IM4402022H8
Reference: IM4402022
EMDN: W01021199
EMDN description: RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
First on market country: Spain
Authorised representative: Humiss International B.V.
Last updated: 14.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

D-IM4401251HJ

Anti-CCP Chemiluminescent Immunoassay Kit

IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent

Manufacturer: Maccura Biotechnology Co., Ltd.
Manufacturer SRN: CN-MF-000014618
UDI-DI: D-IM4401251HJ
Basic UDI-DI: B-IM4401251HJ
Reference: IM4401251
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 14.07.2026 01:16

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor RF

I0233

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0233NF
Basic UDI-DI: B-I0233NF
Reference: I0233
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:03

Manufacturer products View details

C‐Reactive Protein (CRP)

I0231

IVD generalIVDDOn the marketAnimal tissuesCompanion diagnosticsKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0231NB
Basic UDI-DI: B-I0231NB
Reference: I0231
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:03

Manufacturer products View details

Antistreptolysin O (ASO)

I0230

IVD generalIVDDOn the marketCompanion diagnosticsHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: C.P.M. COMPAGNIA PER LA MEDICINA S.R.L.
Manufacturer SRN: IT-MF-000010738
UDI-DI: D-I0230N9
Basic UDI-DI: B-I0230N9
Reference: I0230
EMDN: W01021104
EMDN description: ANTI-STREPTOLYSIN O (QUANTITATIVE)
First on market country: Italy
Authorised representative: -
Last updated: 14.07.2026 01:03

Manufacturer products View details

High Sensitivity C-Reactive Protein Reagent Kit

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-HS-CRP6018H
Basic UDI-DI: B-HS-CRP6018H
Reference: HS-CRP6011Y,HS-CRP6012Y,HS-CRP6013Y,HS-CRP6014Y,HS-CRP6015Y,HS-CRP6011N,HS-CRP6012N,HS-CRP6013N,HS-CRP6014N,HS-CRP6015N
EMDN: W01021109
EMDN description: C-REACTIVE PROTEIN
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 14.07.2026 00:57

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor IgM Rapid Test Cassette (Serum/Plasma)

GGRF(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Zhejiang Orient Gene Biotech Co., Ltd
Manufacturer SRN: CN-MF-000017965
UDI-DI: D-GGRF(IgM)-302aWT
Basic UDI-DI: B-GGRF(IgM)-302aWT
Reference: GGRF(IgM)-302a
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Spain
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details

Rheumatoid Factor IgM Rapid Test Cassette (Serum/Plasma)

GGRF(IgM)-302a

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use

Manufacturer: Healgen Scientific Limited Liability Company
Manufacturer SRN: US-MF-000018839
UDI-DI: D-GGRF(IgM)-302aHGWJ
Basic UDI-DI: B-GGRF(IgM)-302aHGWJ
Reference: GGRF(IgM)-302a
EMDN: W01021110
EMDN description: RHEUMATOID FACTORS
First on market country: Germany
Authorised representative: CMC Medical Devices & Drugs SL
Last updated: 14.07.2026 00:36

Manufacturer products Authorised representative products Authorised representative actors View details