IFCAN quality certificates.爱复康质量与资质证书。
IFCAN maintains documented quality management and regulated manufacturing qualifications in China. The certificates below include medical device production/business qualifications and product registration certificates covering controls, calibrators and assay kits used around specific-protein and IVD reagent workflows.爱复康建立了文件化质量管理体系，并具备中国境内医疗器械相关生产与经营资质。以下证书包括医疗器械生产/经营资质，以及覆盖质控品、校准品、检测试剂盒等产品方向的体外诊断试剂注册证。
Compliance support for upstream IVD material buyers为上游 IVD 原料采购提供合规支撑
Business license, medical device manufacturing license and Class II medical device business filing indicate the company's regulated operating scope in China.营业执照、医疗器械生产许可证及第二类医疗器械经营备案，体现公司在中国境内的合规经营与生产范围。
The product registrations cover controls, calibrators and assay-kit categories related to specific proteins, immunoglobulins, complement, inflammation, renal/gastric function, lipids and coagulation markers.产品注册证覆盖质控品、校准品和检测试剂盒，涉及特定蛋白、免疫球蛋白、补体、炎症、肾功能/胃功能、脂代谢及凝血相关指标。
For overseas raw-material evaluation, IFCAN can provide product information, COA/SDS or other lot documentation subject to the exact item and batch.海外客户评估原料时，可按具体产品与批次沟通产品资料、COA/SDS 及相关质量文件。
From company qualification to product registration从企业资质到产品注册
IVD reagent registrations体外诊断试剂注册证
Registration certificates for controls, calibrators and assay kits across common clinical chemistry and immunology marker groups.涵盖临床化学和免疫相关常见指标的质控品、校准品、检测试剂盒注册证。
Operating qualifications经营与生产资质
Business license, medical device manufacturing license and Class II medical device business filing.营业执照、医疗器械生产许可证、第二类医疗器械经营备案凭证。
Credit record certificate信用等级证书
Enterprise credit rating certificate supplied as an additional company background document.企业信用等级证书作为企业背景与信用记录补充资料。
IFCAN certificates and qualifications爱复康证书与资质展示
Click any certificate to open a larger image. For procurement or supplier-audit use, please request the latest official copy from IFCAN before commercial decisions.点击任一证书可查看大图。用于采购或供应商审核时，请在商业决策前向爱复康索取最新正式文件。
NMPA IVD reagent registration certificate体外诊断试剂注册证01 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证02 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证03 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证04 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证05 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证06 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证07 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证08 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证09 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证10 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证11 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证12 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证13 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证14 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证15 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证16 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证17 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证18 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证19 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证20 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证21 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证22 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证23 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证24 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证25 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证26 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证27 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证28 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证29 · Product registration产品注册
NMPA IVD reagent registration certificate体外诊断试剂注册证30 · Product registration产品注册
Prealbumin assay kit registration certificate前白蛋白检测试剂盒注册证31 · Assay kit registration产品注册
Retinol-binding protein assay kit registration certificate视黄醇结合蛋白检测试剂盒注册证32 · Assay kit registration产品注册
Immunoglobulin M calibrator registration certificate免疫球蛋白 M 校准品注册证33 · Calibrator registration产品注册
Lipoprotein(a) calibrator registration certificate脂蛋白(a)校准品注册证34 · Calibrator registration产品注册
Prealbumin calibrator registration certificate前白蛋白校准品注册证35 · Calibrator registration产品注册
Business license营业执照36 · Company qualification企业资质
Medical device manufacturing license医疗器械生产许可证37 · Company qualification企业资质
Class II medical device business filing certificate第二类医疗器械经营备案凭证38 · Company qualification企业资质
Certificate archive overview证书档案概览39 · Certificate archive企业资质
AAA enterprise credit rating certificateAAA 企业信用等级证书40 · Company qualification企业资质
Need supplier-audit documents or product files?需要供应商审核资料或产品文件？
Send the target marker and intended application. IFCAN can help match raw materials and provide available documentation for evaluation.发送目标 marker 与应用场景，IFCAN 可协助匹配原料，并提供可用于评估的相关资料。
