QUALITY & DOCUMENTATION
Evidence with
a clearly defined scope.
Documents belong to the entity named on them. A quality-system certificate or patent is not a product approval for every model or destination.
QUALITY MANAGEMENT SYSTEM
ISO 13485:2016
Holder: Hongchuang Medical Instrument (Changzhou) Co., Ltd.
Period shown: 3 June 2026 – 2 June 2029.
The published scope includes manufacture of specified surgical devices and components, with an export-only qualification. Refer to the original image for the exact wording and request the current full-resolution certificate for due diligence.
This is the manufacturing entity’s quality-system certificate, not a certificate issued to Hongye and not a blanket product approval.
Open certificate image →INTELLECTUAL PROPERTY
Bipolar vessel-sealing instrument patent
Named holder: Hongchuang Medical Instrument (Changzhou) Co., Ltd.
Publication number: CN119745500B.
Grant date shown: 12 September 2025.
This published patent document concerns intellectual property. It is not evidence of clinical performance, product certification or marketing authorization.
Open patent image →Before regulatory or supplier qualification review
Request the exact legal manufacturer, current document version, covered product models and destination-market requirements. We do not present CE badges, IEC icons or unrelated group documents as proof that every product in this catalogue holds those approvals.
Source: selected document images published on the H-Group official certifications page, reviewed on 20 September 2026. Public images have not been independently authenticated with the issuer.
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