- 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
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
01.08.2026 00:16
Sync status
Successful
Device
2988209
Actor
47512
Certificate
3174
IVD Class BIVDR 2017/746On the marketAnimal tissuesKitProfessional testingReagent
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
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
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
- 06942359515603
- Basic UDI-DI
- 697015090000116H4
- Reference
- CMQ1401
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Italy
- Authorised representative
- QbD RepS BV
- Last updated
- 31.07.2026 20:48
06926802604403
Anti-CCP (CLIA)
IVD Class BIVDR 2017/746No longer on the marketAnimal tissuesHuman tissuesKitProfessional testingReagentSingle use
- Manufacturer
- MEDCAPTAIN MEDICAL TECHNOLOGY CO., LTD.
- Manufacturer SRN
- CN-MF-000005925
- UDI-DI
- 06926802604403
- Basic UDI-DI
- 69268026MD72C00001V3
- Reference
- MCL03601E
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- -
- Authorised representative
- R Sight B.V.
- Last updated
- 31.07.2026 18:41
iFlash-Anti-CCP
iFlash-Anti-CCP
IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- SHENZHEN YHLO BIOTECH CO., LTD.
- Manufacturer SRN
- CN-MF-000001137
- UDI-DI
- 06925912718666
- Basic UDI-DI
- 692591270044H5
- Reference
- C89017G
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 31.07.2026 18:31
Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Detection Kit (Nephelometry)
Anti-cyclic Citrullinated Peptide Antibody (Anti-CCP) Detection Kit (Nephelometry)
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- Genrui Biotech Inc.
- Manufacturer SRN
- CN-MF-000017351
- UDI-DI
- 06950334819653
- Basic UDI-DI
- B-06950334819653
- Reference
- 32027180
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Türkiye
- Authorised representative
- Medunion S.L.
- Last updated
- 28.07.2026 00:36
Atellica IM anti-CCP IgG (aCCP)
IVDR_67_TTN_DUB-C_B_KIT_aCCP
IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Inc.
- Manufacturer SRN
- US-MF-000016560
- UDI-DI
- 00630414245669
- Basic UDI-DI
- 0405686900746VW
- Reference
- 10732998
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 23.07.2026 22:40
D-R154142L
50 Tests/Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- Rayto Life and Analytical Sciences Co., Ltd.
- Manufacturer SRN
- CN-MF-000011141
- UDI-DI
- D-R154142L
- Basic UDI-DI
- B-R154142L
- Reference
- R15414
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Ireland
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 22.07.2026 15:03
D-R154132J
200 Tests/Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- Rayto Life and Analytical Sciences Co., Ltd.
- Manufacturer SRN
- CN-MF-000011141
- UDI-DI
- D-R154132J
- Basic UDI-DI
- B-R154132J
- Reference
- R15413
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Ireland
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 22.07.2026 15:03
D-R154122G
100 Tests/Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- Rayto Life and Analytical Sciences Co., Ltd.
- Manufacturer SRN
- CN-MF-000011141
- UDI-DI
- D-R154122G
- Basic UDI-DI
- B-R154122G
- Reference
- R15412
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Ireland
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 22.07.2026 15:03
D-R154112E
50 Tests/Kit
IVD generalIVDDOn the marketKitProfessional testingReagent
- Manufacturer
- Rayto Life and Analytical Sciences Co., Ltd.
- Manufacturer SRN
- CN-MF-000011141
- UDI-DI
- D-R154112E
- Basic UDI-DI
- B-R154112E
- Reference
- R15411
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Ireland
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 22.07.2026 15:03
Anti-Cyclic Citrullinated Peptide Antibody Determination Kit (Fluorescence Immunochromatographic Assay)
25 tests/box
IVD Class BIVDR 2017/746On the marketDirect markingKitProfessional testingReagent
- Manufacturer
- Beijing Diagreat Biotechnologies Co., Ltd.
- Manufacturer SRN
- CN-MF-000019511
- UDI-DI
- 06942293581238
- Basic UDI-DI
- 697518250P115086K
- Reference
- P11508
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Italy
- Authorised representative
- Medunion S.L.
- Last updated
- 21.07.2026 23:04
IMMULITE 2000 Anti-CCP IgG
IVDR_67_LLB_DUB-C_B_REAG_KIT_Anti-CCP IgG
IVD Class BIVDR 2017/746On the marketAnimal tissuesHuman tissuesKitProfessional testingReagent
- Manufacturer
- Siemens Healthcare Diagnostics Products Ltd.
- Manufacturer SRN
- GB-MF-000016339
- UDI-DI
- 00630414982151
- Basic UDI-DI
- 0405686901368VT
- Reference
- 10368607
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Germany
- Authorised representative
- Siemens Healthcare Diagnostics Manufacturing Limited
- Last updated
- 16.07.2026 00:27
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagentSingle use
- Manufacturer
- VivaChek Biotech (Hangzhou) Co., Ltd.
- Manufacturer SRN
- CN-MF-000012160
- UDI-DI
- D-VID119F2
- Basic UDI-DI
- B-VID119F2
- Reference
- VID119-01-011
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Italy
- Authorised representative
- Lotus NL B.V.
- Last updated
- 15.07.2026 13:20
D-TD-HNKX-CED-704A
Anti-cyclic Citrullinated Peptide Antibody Kit (Microfluidic Fluorescent Immunoassay)
IVD generalIVDDOn the marketAnimal tissuesKitMicrobial substancesProfessional testingReagent
- Manufacturer
- Hunan Kangxin Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000020121
- UDI-DI
- D-TD-HNKX-CED-704A
- Basic UDI-DI
- B-TD-HNKX-CED-704A
- Reference
- /
- EMDN
- W01021112
- EMDN description
- ANTI-CYCLIC CITRULLINATED PEPTIDE
- First on market country
- Spain
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 15.07.2026 10:57
D-IM4408251K3
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-IM4408251K3
- Basic UDI-DI
- B-IM4408251K3
- Reference
- IM4408251
- 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 01:30
D-IM4407251JU
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-IM4407251JU
- Basic UDI-DI
- B-IM4407251JU
- Reference
- IM4407251
- 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 01:29
D-IM4406251JM
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-IM4406251JM
- Basic UDI-DI
- B-IM4406251JM
- Reference
- IM4406251
- 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 01:27
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