About Us

Certificates

  • Quality Certificates

  •          1st EU MDD CE & ISO13485 Certificates of NPWT in China (by TÜV SÜD)
             1st EU MDD CE & ISO13485 Certificates of PU NPWT Dressing Kit in China (by SGS)
             1st EU MDR CE Certificate of NPWT Pump in China (by SGS)
             1st EU MDR CE Certificate of NPWT Dressing Kit in China (by SGS)
             1st EU MDR CE Certificate of NPWT System in China (by SGS)
             1st US FDA 510(k) Clearance of NPWT Device in China
             1st US FDA Site Audit Pass of NPWT Device in China


  • Audits Passed

  • ISO13485 & MDD 93/42/EEC Audit by SGS
    ISO13485 & MDD 93/42/EEC Audit by TÜV SÜD
    QSR820 (21CFR PART820) Site Audit by US FDA
    Site Audit by the Ministry of Health of Kazakhstan
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