Certificates Factory Certification The following is the qualification certificate of our factory: NewScen Coast Bio-Pharmaceutical Co., Ltd.Click thumbnails to see the details Certificate: EN ISO 13485 : 2016 Issue Date: 2022/09/20 Expiry Date: 2025/10/20 Issued By: TรV Report No.: SH22107301 Certificate: EN ISO 13485 : 2016 Issue Date: 2022/09/20 Expiry Date: 2025/10/20 Issued By: TรV Report No.: SH22107301 Certificate: ISO 9001 : 2015 Issue Date: 2022/11/10 Expiry Date: 2025/11/24 Issued By: TรV Report No.: SH22107301 Certificate: EN ISO 13485 : 2016 Issue Date: 2022/09/20 Expiry Date: 2025/10/20 Issued By: TรV Report No.: SH22107301 Product Certification We can provide the following product certifications to all of our global partner customers. TรV Products: HCG, LH, FSH, FOB, SF, HIV, HCV Certificate: CE Issue Date: 2022/05/02 Expiry Date: 2025/05/26 Issued By: TรV Method: Lateral Flow Assay (Immunochromatography Assay) TรV Products: HCG, LH, FSH, FOB, SF, HIV, HCV Certificate: CE Issue Date: 2022/05/02 Expiry Date: 2025/05/26 Issued By: TรV Method: Lateral Flow Assay (Immunochromatography Assay) MHRA Products: PCT, CRP, AFP, CEA, cTnI, D-Dimer, mAlb, TSH, HCG, LH, FSH, SF, FOB, HIV, HCVCertificate: CEIssue Date: 2022/04/28Expiry Date: IndefiniteIssued By: MHRAMethod: Lateral Flow Assay (Immunochromatography Assay) ECrep (IVDDย 8others&5ST) ECrep (IVDDย ListAย 30829&65847) ECrep (IVDDother-COVID-65756) ECrep (IVDDotherย COVIDย IgGIgMย 64839) NewScen List RIOMAVIX Products: ย MDT, CHIK IgG/IgM, ZIKA IgG/IgM, ZIKA NS1Ag, DEN IgG/IgM, DEN NS1 Ag,MAR Pf/Pan, HPAb, HPAg, TB, TF, TPCertificate: CEIssue Date: 2022/03/08Expiry Date: IndefiniteIssued By: RIOMAVIXMethod: Lateral Flow Assay (Immunochromatography Assay) One Step Multiple Drug Test Chikungunya IgG+IgM Rapid Test Zika Virus IgG+IgM Rapid Test Zika NS1 Antigen Rapid Test Dengue IgG+IgM Rapid Test Dengue NS1 Antigen Rapid Test Malaria Pf+Pan Antigen Rapid Test H.Pylori (HP) Antibody Rapid Test H.Pylori (HP) Antigen Rapid Test M.Tuberculosis (TB) Antibody Rapid Test Transferrin (TF) Rapid Test Treponema Pallidum (TP) Antibody Rapid Test NMPA Products: HIV, HCV, TP, TB, HPAg, HPAb, FOB, SFย Certificate: NMPAIssue Date:ย HIV 2019/04/08, HCV 2021/01/12, TP 2020/07/01, TB 2019/04/08,HPAg/HPAb 2022/06/29, FOB/SF 2022/06/19Expiry Date: HIV 2024/04/07, HCV 2026/01/11, TP 2025/06/30, TB 2024/04/07,HPAg/HPAb 2027/06/28, FOB/SF 2027/06/18Issued By: NMPAMethod: Lateral Flow Assay (Immunochromatography Assay) HIV NMPA HCV NMPA 2021-2026 TP NMPA TB NMPA HPAg NMPA 2022-2027 HPAb NMPA 2022-2027 FOB NMPA 20220619-20270618 SF B NMPA 20220619 20270618