- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- D-GDCRP-402a3X
- Basic UDI-DI
- B-GDCRP-402a3X
- Reference
- GDCRP-402a
- EMDN
- W01021109
- EMDN description
- C-REACTIVE PROTEIN
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 14.07.2026 00:33
Public EUDAMED Search
EUDAMED Device Search
A readable public search layer for EUDAMED device, manufacturer, UDI, EMDN and risk class data.
Last updated
25.09.2026 08:24
Sync status
Successful
Device
3654355
Actor
47913
Certificate
3410
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingSingle use
CRP Quantitative Test Kit (Time-Resolved FIA)
CRP Quantitative Test Kit (Time-Resolved FIA)
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Healgen Scientific Limited Liability Company
- Manufacturer SRN
- US-MF-000018839
- UDI-DI
- D-FDWCR-402aHGAZ
- Basic UDI-DI
- B-FDWCR-402aHGAZ
- Reference
- FDWCR-402a
- EMDN
- W01021109
- EMDN description
- C-REACTIVE PROTEIN
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 13.07.2026 21:23
CRP Quantitative Test Kit (Time-Resolved FIA)
CRP Quantitative Test Kit (Time-Resolved FIA)
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- D-FDWCR-402a7R
- Basic UDI-DI
- B-FDWCR-402a7R
- Reference
- FDWCR-402a
- EMDN
- W01021109
- EMDN description
- C-REACTIVE PROTEIN
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 13.07.2026 21:23
SAA QuantitativeTest Kit (Time-Resolved FIA)
SAA QuantitativeTest Kit (Time-Resolved FIA)
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Zhejiang Orient Gene Biotech Co., Ltd
- Manufacturer SRN
- CN-MF-000017965
- UDI-DI
- D-FDSAA-402aVB
- Basic UDI-DI
- B-FDSAA-402aVB
- Reference
- FDSAA-402a
- EMDN
- W01021199
- EMDN description
- RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 13.07.2026 21:22
SAA QuantitativeTest Kit (Time-Resolved FIA)
SAA QuantitativeTest Kit (Time-Resolved FIA)
IVD generalIVDDOn the marketKitNear-patient testingProfessional testingReagentSingle use
- Manufacturer
- Healgen Scientific Limited Liability Company
- Manufacturer SRN
- US-MF-000018839
- UDI-DI
- D-FDSAA-402aHGTR
- Basic UDI-DI
- B-FDSAA-402aHGTR
- Reference
- FDSAA-402a
- EMDN
- W01021199
- EMDN description
- RHEUMATOID / INFLAMMATORY DISEASE MARKERS - OTHER
- First on market country
- Germany
- Authorised representative
- CMC Medical Devices & Drugs SL
- Last updated
- 13.07.2026 21:22
D-ECH05063147L
Anti-Streptolysin O (ASO)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH05063147L
- Basic UDI-DI
- B-ECH05063147L
- Reference
- ECH0506314
- EMDN
- W01021104
- EMDN description
- ANTI-STREPTOLYSIN O (QUANTITATIVE)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:46
D-ECH05053147D
Anti-Streptolysin O (ASO)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH05053147D
- Basic UDI-DI
- B-ECH05053147D
- Reference
- ECH0505314
- EMDN
- W01021104
- EMDN description
- ANTI-STREPTOLYSIN O (QUANTITATIVE)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:46
D-ECH050431476
Anti-Streptolysin O (ASO)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH050431476
- Basic UDI-DI
- B-ECH050431476
- Reference
- ECH0504314
- EMDN
- W01021104
- EMDN description
- ANTI-STREPTOLYSIN O (QUANTITATIVE)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:45
D-ECH05033146X
Anti-Streptolysin O (ASO)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH05033146X
- Basic UDI-DI
- B-ECH05033146X
- Reference
- ECH0503314
- EMDN
- W01021104
- EMDN description
- ANTI-STREPTOLYSIN O (QUANTITATIVE)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:45
D-ECH05023146Q
Anti-Streptolysin O (ASO)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH05023146Q
- Basic UDI-DI
- B-ECH05023146Q
- Reference
- ECH0502314
- EMDN
- W01021104
- EMDN description
- ANTI-STREPTOLYSIN O (QUANTITATIVE)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:44
D-ECH05013146H
Anti-Streptolysin O (ASO)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH05013146H
- Basic UDI-DI
- B-ECH05013146H
- Reference
- ECH0501314
- EMDN
- W01021104
- EMDN description
- ANTI-STREPTOLYSIN O (QUANTITATIVE)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:43
D-ECH010731569
Rheumatoid Factor (RF)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH010731569
- Basic UDI-DI
- B-ECH010731569
- Reference
- ECH0107315
- EMDN
- W01021110
- EMDN description
- RHEUMATOID FACTORS
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:38
D-ECH010631562
Rheumatoid Factor (RF)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH010631562
- Basic UDI-DI
- B-ECH010631562
- Reference
- ECH0106315
- EMDN
- W01021110
- EMDN description
- RHEUMATOID FACTORS
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:37
D-ECH01063145Y
Anti-Streptolysin O (ASO)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01063145Y
- Basic UDI-DI
- B-ECH01063145Y
- Reference
- ECH0106314
- EMDN
- W01021104
- EMDN description
- ANTI-STREPTOLYSIN O (QUANTITATIVE)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:37
D-ECH01053155T
Rheumatoid Factor (RF)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01053155T
- Basic UDI-DI
- B-ECH01053155T
- Reference
- ECH0105315
- EMDN
- W01021110
- EMDN description
- RHEUMATOID FACTORS
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:37
D-ECH01053145R
Anti-Streptolysin O (ASO)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01053145R
- Basic UDI-DI
- B-ECH01053145R
- Reference
- ECH0105314
- EMDN
- W01021104
- EMDN description
- ANTI-STREPTOLYSIN O (QUANTITATIVE)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:37
D-ECH01053035L
C-reactive protein (CRP)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01053035L
- Basic UDI-DI
- B-ECH01053035L
- Reference
- ECH0105303
- EMDN
- W01021109
- EMDN description
- C-REACTIVE PROTEIN
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:37
D-ECH01043155L
Rheumatoid Factor (RF)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01043155L
- Basic UDI-DI
- B-ECH01043155L
- Reference
- ECH0104315
- EMDN
- W01021110
- EMDN description
- RHEUMATOID FACTORS
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:35
D-ECH01043145J
Anti-Streptolysin O (ASO)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01043145J
- Basic UDI-DI
- B-ECH01043145J
- Reference
- ECH0104314
- EMDN
- W01021104
- EMDN description
- ANTI-STREPTOLYSIN O (QUANTITATIVE)
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:35
D-ECH01013154X
Rheumatoid Factor (RF)
IVD generalIVDDOn the marketAnimal tissuesKitProfessional testingReagent
- Manufacturer
- Maccura Biotechnology Co., Ltd.
- Manufacturer SRN
- CN-MF-000014618
- UDI-DI
- D-ECH01013154X
- Basic UDI-DI
- B-ECH01013154X
- Reference
- ECH0101315
- EMDN
- W01021110
- EMDN description
- RHEUMATOID FACTORS
- First on market country
- Germany
- Authorised representative
- Shanghai International Holding Corp. GmbH(Europe)
- Last updated
- 13.07.2026 18:35