Quality

QC/Technical Support

As a manufacturer of medical products we are subject to strict EN ISO13485;2003 Quality Management System. EN13795 standards, and the guideline MDD93/42/EEC, we are CE certified by TUV and with FDA registration.

Medical devices, validation and routine control of Ethylene Oxide sterilization.

International sterilization Standard-ANSI, AAMI, ISO7135 and EN550 are applied.

Standard: CE Number: G2S140387179002 Issue Date: 2019-03-07 Expiry Date: 2024-03-07 Scope/Range: Surgical Issued By: TUV

Standard: ISO Number: G2S140387179002 Issue Date: 2019-03-07 Expiry Date: 2024-03-07 Scope/Range: Surgical Issued By: TUV

Standard: TEST REPORT Number: GZHT02294013 Issue Date: 2019-03-07 Expiry Date: 2024-03-07 Scope/Range: Surgical Issued By: TUV

Standard: CE Number: G2S140387179002 Issue Date: 2019-03-07 Expiry Date: 2024-03-07 Scope/Range: Surgical Issued By: TUV

Standard: ISO Number: G2S140387179002 Issue Date: 2019-03-07 Expiry Date: 2024-03-07 Scope/Range: Surgical Issued By: TUV

Standard: TUV Number: G2S140387179003 Issue Date: 2019-03-07 Expiry Date: 2024-03-07 Scope/Range: Surgical Issued By: TUV