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
Complement 3 (C3) Ref ECH0504309
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPepsinogen II Chemiluminescent Immunoassay Kit Ref IM4407128
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSample Diluent No.3 Ref IM4201463
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:A5′-Nucleotidase (5'-NT) Control Ref ECH0192218
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSARS-CoV-2 IgG (CLIA) Ref EIM4401014
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-thyroid peroxidase antibodies (Anti-TPO) Calibrators (Chemiluminescent Immunoassay) Ref EIM4283057
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-Streptolysin O (ASO) Ref ECH0106314
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Generalα1-Microglobulin (α1-MG) Control Ref ECH0191062
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralLipid & Immunology Multiple (LIM) Control Ref ECH0194511
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralProgesterone Calibrators Ref EIM4282006
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralLh Ref EIM4205004
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralThyroid Autoantibodies Control Ref EIM4294503
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:Bhigh sensitive C-reactive protein (hs-CRP) Assay Kit by Immune Scattered Nephelometry Method Ref CH0603311
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycosylated Hemoglobin A1c (HbA1c) Control Ref ECH0191104
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralLipoprotein (a)(LP(a)) Ref ECH0109163
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCoagulation Quality Control Plasma (CQC) Ref EBL2198001
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUrine Test Strips Ref HU5101007
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralLipoprotein (a)(LP(a)) Ref ECH0502163
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPrealbumin (PA) Ref ECH0504007
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCk-Mb (Clia) Ref IM4408152
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHypertension Marker Control Ref IM4496471
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralT4 Calibrators Ref EIM4282052
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Generalβ2-Microglobulin (β2-MG) Calibrator Ref ECH0186055
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHematology Analyzer Control Ref EBL2203004
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-SSA(Ro52) Antibody Chemiluminescent Immunoassay Kit Ref IM4411257
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BAnti-CENP-B Antibody Chemiluminescent Immunoassay Kit Ref IM4409262
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
RF Chemiluminescent Immunoassay Kit Ref IM4415268
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Anti-SSB(La) Antibody Chemiluminescent Immunoassay Kit Ref IM4407258
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BHematology Analyzer Control Ref EBL2202002
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNT-proBNP (CLIA) Ref IM4402154
None Regimes: CE, no status data Registry: EUDAMED ClassClass:IVD GeneralAnti-TPO (CLIA) Ref IM4403057
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMaternal Control Ref EIM4293507
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Anti-CENP-B Antibody Chemiluminescent Immunoassay Kit Ref IM4402262
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnemia Markers Control Ref IM4495076
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BHematology Analyzer Fluorescent Platelets Calibrator Ref EBL2286101
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPrealbumin (PA) Ref ECH0506007
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHematology Analyzer Control Ref EBL2202004
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHuman Growth Hormone Chemiluminescent Immunoassay Kit Ref IM4406206
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:B- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
Automatic Hematology Analyzer GD-5 Diluent A Ref BL2201008
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:Aα1-Microglobulin (α1-MG) Control Ref ECH0194062
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHSV-2 IgG Ref EIM4205328
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUrinalysis Sediment Calibrator Ref HU5181004
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHematology Analyzer Reticulocyte Control Ref EBL2223100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralNeutrophil Gelatinase-associated Lipocalin (NGAL) Ref ECH0103061
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHAV IgM Antibody Chemiluminescent Immunoassay Kit Ref IM4405010
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:B- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
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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)