OxySail Dokumentations- und Verifizierungszentrum

Was das Dokument belegt: The document records a conformity verification for the product, legal entity and YCDY-W100 Series scope stated in it.

Was das Dokument nicht belegt: This is not FDA clearance or U.S. market authorization. The document states that the voluntary verification does not itself demonstrate every essential requirement or replace any required notified-body assessment.

Was das Dokument belegt: The report records SGS witnessing of hydrostatic pressure testing for the listed chamber models. The required test pressure was 0.2 MPa(g), actual test pressure was 0.2-0.26 MPa(g), and the reported result was satisfactory with no leakage observed during the required inspection.

Was das Dokument nicht belegt: This is an inspection report for the stated intervention and scope. It is not a medical-device authorization, FDA clearance, or a blanket approval for models not listed in the report.

Was das Dokument belegt: This is a company-level supplier assessment for the named company and assessment period.

Was das Dokument nicht belegt: This is not a product safety certificate, pressure-vessel approval or FDA authorization.