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