Maccura Biotechnology Co., Ltd.
Active in EUDAMEDChinafrom SRN EUDAMED SRN CN-MF-000014618
- Devices
- 1,590
- Registrations
- EUDAMED
DeviceDevice · Authorizations Verified Status Regime Registry Class
- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:B
Anti-CCP Chemiluminescent Immunoassay Kit Ref IM4401251
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGDF-15 Chemiluminescent Immunoassay kit Ref IM4491155
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
SARS-CoV-2 Fluorescent PCR Kit Ref EGN7104110
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralTotal T4 Chemiluminescent Immunoassay Kit Ref IM4405053
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BTriglycerides (TG) Ref ECH0106151
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNeutrophil Gelatinase-associated Lipocalin (NGAL) Control Ref ECH0192061
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPCT Control Ref IM4291333
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralWS Wash Buffer Ref EIM4202465
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:A- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Thyroglobulin Antibody Chemiluminescent Immunoassay Kit Ref IM4406056
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BAnti-LC-1 Antibody Chemiluminescent Immunoassay Kit Ref IM4414470
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD Generalβ-HCG Chemiluminescent Immunoassay Kit Ref IM4406207
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BThyroid autoantibodies Control Ref IM4295503
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAMA-M2 Chemiluminescent Immunoassay Kit Ref IM4410267
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:BHormones Control Ref EIM4492300
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BPepsinogen II Chemiluminescent Immunoassay Kit Ref IM4406128
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPrealbumin (PA) Ref ECH0105007
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAlbumin (Alb) Ref ECH0103002
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycated Hemoglobin A1c (HPLC) Ref BL2507001
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNeutrophil Gelatinase-associated Lipocalin (NGAL) Control Ref ECH0193061
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSARS-CoV-2 IgG (CLIA) Ref EIM4405014
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralT3 Calibrators Ref EIM4283051
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUnconjugated Estriol Calibrators Ref EIM4283008
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPCT Control Ref IM4296333
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralD-Dimer Chemiluminescent Immunoassay Kit Ref IM4491159
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralChemiluminescent Immunoassay Assay Kits for TOXO IgM Ref EIM4415117
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List BAnti-Sm/RNP Antibody Chemiluminescent Immunoassay Kit Ref IM4409254
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:B
T4 Calibrators Ref EIM4283052
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-SSB(La) Antibody Chemiluminescent Immunoassay Kit Ref IM4409258
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BC-reactive protein (CRP) Calibrator Ref ECH0182303
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralW0105010116 Ref EIM4414016
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:B- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Ferritin (CLIA) Ref IM4403201
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
CK & CK-MB Calibrator Ref ECH0182211
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAutomatic Hematology Analyzer LD-5 Lysing Reagent A Ref BL2201005
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:AHAV IgM Antibody Chemiluminescent Immunoassay Kit Ref IM4407010
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:B- Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:B
Alkaline Phosphatase (ALP) Ref ECH0101203
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSARS-CoV-2 Fluorescent PCR Kit Ref EGN7105110
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNSE Chemiluminescent Immunoassay Kit Ref IM4407108
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAutomatic Hematology Analyzer F-LS Lysing Reagent Ref BL2201014
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:AAnti-Jo-1 Antibody Chemiluminescent Immunoassay Kit Ref IM4407454
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:B5′-Nucleotidase (5'-NT) Ref ECH0503218
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralVB12 Chemiluminescent Binding Assay Kit Ref IM4402212
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BAnti-Sm/RNP Antibody Chemiluminescent Immunoassay Kit Ref IM4407255
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BC-reactive protein (CRP) Calibrator Ref ECH0183303
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
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Company details
- EUDAMED SRN
- CN-MF-000014618
- EUDAMED status
- Active since 2023
- EUDAMED registered name
- Maccura Biotechnology Co., Ltd.
- Registered address
- 16#,, Baichuan Road, Hi-tech Zone,, 611731, Chengdu, China
- Website
- www.maccura.com/en/ This address returned "not found" when we last checked — the site may have moved. Last checked 18 Oct 2026.
- [email protected]
- Phone
- +86 28 87826777
- PRRC contact
- Lifang CHEN(public in EUDAMED)