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
Low Density Lipoprotein Cholesterol (LDL-C) Ref ECH0106162
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralTestosterone (CLIA) Ref IM4403210
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralW0105010116 Ref EIM4410016
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BCoagulation Analyzer Wash Buffer A (Coa-Wash A) Ref EBL2101504
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:AS100 Protein Chemiluminescent Immunoassay Kit Ref IM4402074
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-LKM-1 Antibody Chemiluminescent Immunoassay Kit Ref IM4414468
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHematology Control Ref EBL2291002
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-Sm Antibody Chemiluminescent Immunoassay Kit Ref IM4403255
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BHematology Analyzer Reticulocyte Control Ref EBL2217100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHSV-1 IgM Antibody Chemiluminescent Immunoassay Kit Ref IM4423123
None Regimes: CE, no status data Registry: EUDAMED ClassClass:IVD GeneralHEV IgM Antibody Chemiluminescent Immunoassay Kit Ref IM4407043
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralApolipoprotein AⅠ (ApoAⅠ) Ref ECH0501157
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAlbumin (Alb) Ref ECH0106002
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAutomatic Hematology Analyzer F-FD Fluorescent Dye Ref BL2201019
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:AApolipoprotein B (ApoB) Ref ECH0503158
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralE2 (Clia) Ref IM4404209
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:B
Total Bilirubin (TBil) Ref ECH0101003
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralRenin Chemiluminescent Immunoassay Kit Ref IM4402456
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD GeneralComplement 3 (C3) Ref ECH0502309
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFructosamine (FMN) Ref ECH0502110
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralTsh (Clia) Ref IM4405055
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
iPTH Ref EIM4201058
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-Rib-P Antibody Chemiluminescent Immunoassay Kit Ref IM4422261
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHuman Growth Hormone Chemiluminescent Immunoassay Kit Ref IM4402206
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BAnti-sp100 Antibody Chemiluminescent Immunoassay Kit Ref IM4411469
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD GeneralProgesterone (CLIA) Ref IM4408205
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Generalhs-CRP Chemiluminescent Immunoassay Kit Ref IM4402303
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUrine Test Strips Ref HU5101016
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycosylated Hemoglobin A1c (HbA1c) Control Ref ECH0194104
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSARS-CoV-2 IgM (CLIA) Ref EIM4407013
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycated Hemoglobin A1c (HPLC) Kit Ref BL2590001
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General5′-Nucleotidase (5'-NT) Control Ref ECH0198218
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCalcitonin (CLIA) Ref IM4406060
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-sp100 Antibody Chemiluminescent Immunoassay Kit Ref IM4415469
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:BGlycated Hemoglobin A1c (HPLC) Kit Ref BL2508001
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHematology Analyzer Control Ref EBL2203002
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralTestosterone Ref EIM4202009
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
Automatic Hematology Analyzer F-DR Diluent Ref BL2201013
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:ARF Chemiluminescent Immunoassay Kit Ref IM4406268
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD GeneralThyroid autoantibodies Control Ref IM4298503
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycosylated Hemoglobin A1c (HbA1c) Control Ref ECH0195104
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
HSV-1/2 IgM Calibrators Ref EIM4281332
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Generalhigh sensitive C-reactive protein (hs-CRP) Assay Kit by Immune Scattered Nephelometry Method Ref CH0692311
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralThyroid autoantibodies Control Ref IM4291503
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Generalfree β-HCG Calibrators Ref EIM4281002
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Generalhigh sensitive C-reactive protein (hs-CRP) Assay Kit by Immune Scattered Nephelometry Method Ref CH0608311
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)