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
HSV-2 IgG Control Ref EIM4297328
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralEstradiol Chemiluminescent Immunoassay Kit Ref IM4403209
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BAssayed Multiple Chemistry Control (Multi-QC) Ref ECH0191502
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCarbon Dioxide (CO2) Ref ECH0101254
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralProgesterone Ref EIM4201006
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-CCP Antibody Control Ref IM4293551
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycosylated Hemoglobin A1c (HbA1c) Control Ref ECH0192104
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:B
high sensitive C-reactive protein (hs-CRP) Assay Kit by Immune Scattered Nephelometry Method Ref CH0607311
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralLipoprotein (a)(LP(a)) Ref ECH0101163
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralC-Peptide Calibrators Ref EIM4283201
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralChemiluminescence Analyzer Substrate Buffer Ref IM4401451
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:ACortisol Chemiluminescent Immunoassay Kit Ref IM4403455
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAnti-PM-Scl Antibody Chemiluminescent Immunoassay Kit Ref IM4414265
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BHSV-1/2 IgM Calibrators Ref EIM4283332
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFT3 (Clia) Ref IM4405052
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralGlycated Hemoglobin A1c Control Ref BL2596001
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Generalhigh sensitive C-reactive protein (hs-CRP) Assay Kit by Immune Scattered Nephelometry Method Ref CH0601311
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- None Regimes: CE, no status data Registry: EUDAMED ClassClass:IVD General
Lipid & Immunology Multiple (LIM) Control Ref ECH0198511
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSARS-CoV-2 IgM (CLIA) Ref EIM4406013
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralCK & CK-MB Control Ref ECH0192211
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMaternal Control Ref EIM4292507
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralRenin Chemiluminescent Immunoassay Kit Ref IM4406456
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD GeneralRF-IgG Chemiluminescent Immunoassay Kit Ref IM4402269
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- None Regimes: CE, no status data Registry: EUDAMED ClassClass:IVD General
α-Hydroxybutyrate Dehydrogenase (α-HBDH) Ref ECH0501354
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralFibrinogen Degradation Product (FDP) Ref EBL2104007
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
FT3 Ref EIM4203053
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUrine Test Strips Ref HU5101004
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralInsulin Ref EIM4203202
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralThyroid Autoantibodies Control Ref EIM4295503
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:BCholinesterase (ChE) Ref ECH0501217
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralAutomatic Hematology Analyzer DD-5 Fluorescent Dye A Ref BL2201007
Active Regimes: CE IVDR Registry: EUDAMED ClassClass:A- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
Hematology Control Ref EBL2297002
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
FSH Calibrators Ref EIM4283003
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralUrine Test Strips Ref HU5101005
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralMaternal Control Ref EIM4291507
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Generalfree β-HCG Ref EIM4205002
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD GeneralSerum amyloid A Chemiluminescent Immunoassay Kit Ref IM4402022
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDR Registry: EUDAMED ClassClass:B
Down Syndrome Markers Control Ref IM4291507
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD Generalanti-TP Control Ref IM4291323
Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General- Active Regimes: CE IVDD Registry: EUDAMED ClassClass:IVD General
- Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass:IVD General
RF-IgA Chemiluminescent Immunoassay Kit Ref IM4403271
Active Regimes: CE IVDR CE IVDD Registry: EUDAMED ClassClass: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)