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105 device results listed.

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D-IM4404251J7

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-IM4404251J7
Basic UDI-DI: B-IM4404251J7
Reference: IM4405251
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 01:24

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

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-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

iStar-Anti-CCP

2×50 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76368GC
Basic UDI-DI: B-DC76368GC
Reference: DC76368
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Anti-CCP

2×25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76367GA
Basic UDI-DI: B-DC76367GA
Reference: DC76368
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Anti-CCP

25 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76366G8
Basic UDI-DI: B-DC76366G8
Reference: DC76366
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Anti-CCP

30 Tests/kit

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76365G6
Basic UDI-DI: B-DC76365G6
Reference: DC76365
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 13.07.2026 16:13

Manufacturer products Authorised representative products Authorised representative actors View details

iStar-Anti-CCP

30 Tests

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shenzhen Drawray Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000008763
UDI-DI: D-DC76063FK
Basic UDI-DI: B-DC76063FK
Reference: DC76063
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Netherlands
Authorised representative: Lotus NL B.V.
Last updated: 13.07.2026 16:03

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP Anti-Cyclic Citrullinated Peptides Antibody (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Hangzhou Aichek Medical Technology Co., Ltd.
Manufacturer SRN: CN-MF-000028093
UDI-DI: D-ACCP706-AEKR
Basic UDI-DI: B-ACCP706-AEKR
Reference: ACCP706-AE10Y, ACCP706-AE10N, ACCP706-AE20Y, ACCP706-AE20N
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Spain
Authorised representative: Medunion S.L.
Last updated: 12.07.2026 21:28

Manufacturer products Authorised representative products Authorised representative actors View details

CCP IgG

IVD generalIVDDOn the marketKitProfessional testingSingle use

Manufacturer: NEOMEDICA DOO NIŠ
Manufacturer SRN: RS-MF-000021305
UDI-DI: 86060147196738
Basic UDI-DI: B-86060147196738
Reference: N702A24IGG
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Northern Ireland
Authorised representative: Wellkang Ltd
Last updated: 12.07.2026 10:14

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-CCP assay (CLIA)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent

Manufacturer: Xiamen Boson Biotech Co., Ltd.
Manufacturer SRN: CN-MF-000001096
UDI-DI: D-7M26FE
Basic UDI-DI: B-7M26FE
Reference: 7M26V1-B-EU, 7M26U1-B-EU, 7M26P1-B-EU
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: MedPath GmbH
Last updated: 12.07.2026 09:28

Manufacturer products Authorised representative products Authorised representative actors View details

iFlash-Anti-CCP

IVD Class BNot specifiedOn the market

Manufacturer: SHENZHEN YHLO BIOTECH CO., LTD.
Manufacturer SRN: CN-MF-000001137
UDI-DI: 06925912723233
Basic UDI-DI: 692591270044H5
Reference: C89017G-S
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: Shanghai International Holding Corp. GmbH(Europe)
Last updated: 11.07.2026 13:48

Manufacturer products Authorised representative products Authorised representative actors View details

TruVue

Anti-CCP Test (FIA)

IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: BioFynder Limited
Manufacturer SRN: UK-MF-000047512
UDI-DI: 15065023763693
Basic UDI-DI: B-15065023763693
Reference: TV20031
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Poland
Authorised representative: SUNGO Europe B.V.
Last updated: 11.07.2026 08:36

Manufacturer products Authorised representative products Authorised representative actors View details

D-11C7G

Anti-Cyclic Citrullinated Peptide Antibody Assay Kit (Latex Immunoturbidimetric Method)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: Shanghai Kehua Bio-engineering Co., Ltd.
Manufacturer SRN: CN-MF-000026756
UDI-DI: D-11C7G
Basic UDI-DI: B-11C7G
Reference: /
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Belgium
Authorised representative: QbD RepS BV
Last updated: 11.07.2026 05:52

Manufacturer products Authorised representative products Authorised representative actors View details

RapidFor™ Anti-CCP Plus Rapid Test Kit (FIA)

VMPO77

IVD generalIVDDOn the marketCompanion diagnosticsKitNear-patient testingProfessional testingReagentSingle use

Manufacturer: Vitrosens Biotechnology Inc.
Manufacturer SRN: TR-MF-000026452
UDI-DI: 08683548255426
Basic UDI-DI: B-08683548255426
Reference: VMPO77
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Germany
Authorised representative: -
Last updated: 09.07.2026 00:14

Manufacturer products View details

08435287148602

ANTI-CITRULLINATED PROTEIN ANTIBODIES (ACPA)

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagent

Manufacturer: BIOSYSTEMS S.A.
Manufacturer SRN: ES-MF-000000231
UDI-DI: 08435287148602
Basic UDI-DI: B-08435287148602
Reference: 44860
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Spain
Authorised representative: -
Last updated: 07.07.2026 23:50

Manufacturer products View details

QUANTA Lite

QUANTA Lite® CCP3 IgG ELISA

IVD generalIVDDOn the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use

Manufacturer: Inova Diagnostics. Inc.
Manufacturer SRN: US-MF-000017851
UDI-DI: 08426950448358
Basic UDI-DI: B-08426950448358
Reference: 704535
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Italy
Authorised representative: Medical Technology Promedt Consulting GmbH
Last updated: 07.07.2026 23:18

Manufacturer products Authorised representative products Authorised representative actors View details

06979878281160

Anti-CCP Test (Fluorescence Immunoassay)

IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use

Manufacturer: Huzhou Jierunxin Biotechnology Co., LTD
Manufacturer SRN: CN-MF-000047637
UDI-DI: 06979878281160
Basic UDI-DI: B-06979878281160
Reference: 1001014
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Austria
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:50

Manufacturer products Authorised representative products Authorised representative actors View details

Anti-Cyclic Citrullinated Peptide Antibody (Anti-CCP) Test Kit

P1403CC

IVD generalIVDDOn the marketKitNear-patient testingReagentSingle use

Manufacturer: Nanjing Vazyme Medical Technology Co.,Ltd.
Manufacturer SRN: CN-MF-000031032
UDI-DI: 06979469761057
Basic UDI-DI: B-06979469761057
Reference: P1403CC
EMDN: W01021112
EMDN description: ANTI-CYCLIC CITRULLINATED PEPTIDE
First on market country: Spain
Authorised representative: RIOMAVIX SOCIEDAD LIMITADA
Last updated: 07.07.2026 02:42

Manufacturer products Authorised representative products Authorised representative actors View details