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
Anti-gp210 Antibody Chemiluminescent Immunoassay Kit Ref IM4414471
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
HCG Calibrators Ref EIM4283001
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFree T4 Chemiluminescent Immunoassay Kit Ref IM4401054
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BPIVKA-II Chemiluminescent Immunoassay Kit Ref IM4403129
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCuvettes Ref CH0800128
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:APrl Ref EIM4205005
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCoagulation Quality Control Plasma (CQC) Ref EBL2197001
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSARS-CoV-2 Fluorescent PCR Ref EGN7103109
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHSV-1/2 IgG Control Ref EIM4292327
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUrea Ref ECH0105051
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUrine Test Strips Ref HU5106002
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCreatinine (Crea) Assay Kit by SAO Method Ref ECH0101053
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCarbon Dioxide (CO2) Ref ECH0502254
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPRL Calibrators Ref EIM4283005
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralTg (CLIA) Ref IM4404059
None Regimes: CE, no status data Registry: EUDAMED ClassClass:IVD GeneralSerum amyloid A Chemiluminescent Immunoassay Kit Ref IM4406022
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAutomatic Hematology Analyzer F-CC Cell Clean Ref EBL2202025
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:AInsulin & C-Peptide Control Ref EIM4292505
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralcTnI (CLIA) Ref IM4406153
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSARS-CoV-2 Real time Fluorescent PCR Kit Ref GN7103121
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralThyroid Function Control Ref EIM4486051
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BAutomatic Hematology Analyzer F-FA Fluorescent Dye Ref BL2201022
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:AHSV-1/2 IgG Control Ref EIM4298327
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycosylated Hemoglobin A1c (HbA1c) Calibrator Ref ECH0181104
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralRheumatoid Factor (RF) Ref ECH0101315
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHematology Analyzer Reticulocyte Control Ref EBL2226100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUrine Test Strips Ref HU5101015
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGDF-15 Chemiluminescent Immunoassay kit Ref IM4407155
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCreatine Kinase (CK) Ref ECH0106210
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFerritin Chemiluminescent Immunoassay Kit Ref IM4407201
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BProgesterone Ref EIM4206006
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
Serum amyloid A Chemiluminescent Immunoassay Kit Ref IM4492022
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHematology Analyzer Reticulocyte Control Ref EBL2219100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHSV-1/2 IgG Calibrators Ref EIM4283327
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-PCNA Antibody Chemiluminescent Immunoassay Kit Ref IM4411266
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Anti-CCP Antibody Control Ref IM4292551
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralLipoprotein (a)(LP(a)) Ref ECH0504163
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-SSB(La) Antibody Chemiluminescent Immunoassay Kit Ref IM4402258
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BMaternal Control Ref EIM4295507
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General5′-Nucleotidase (5'-NT) Ref ECH0101218
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralPrl Ref EIM4206005
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Annex II List B
5′-Nucleotidase (5'-NT) Control Ref ECH0196218
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralHematology Analyzer Reticulocyte Control Ref EBL2209100
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCreatinine (Crea) Assay Kit by SAO Method Ref ECH0503053
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD General
Glycated Hemoglobin A1c Control Ref BL2591002
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)