ISO 13485:2016 Quality Management System – Jiangxi Hongda (Rev. 05)

Design and development, production and sales of listed single-use medical consumables and in vitro diagnostic consumables (vacuum blood collection tubes). Site-specific activities are detailed on page 2.

Certificate holder	Jiangxi Hongda Medical Equipment Group Ltd.
Standard	ISO 13485:2016; EN ISO 13485:2016/AC:2018; EN ISO 13485:2016/A11:2021
Reference	Q5 044803 0033 Rev. 05
Issuer	TÜV SÜD Product Service GmbH
Applicable scope	Design and Development, Production and Sales of Infusion sets for single use, Transfusion sets for single use, Syringes for single use, Sterile needles for single use, scalp vein sets for single use, Blood collection needles for single use, Urine Bag for Single Use, Sterile Single-Use Dental Injection Needles, Vagina Dilator for Single Use, Sterile Autodisable Syringe for Single Use, Disposable Suction Catheter for use in Respiratory Tract, Disposable Stomach Catheter, Single-use Sterile rubber surgical gloves, Single-use medical examination gloves, Disposable sterile needle retractable safety syringe, IV Cannula for single use, Foley Catheter for single use, Extension tube for single use, Endotracheal tube for single use, A.V. fistula needle sets for single use, Burette-type infusion sets for single use, Heparin cap for single use, Sterile insulin syringe for single use, Nasal oxygen cannula for single use, Blood Tubing Sets for Hemodialysis, Feeding tube for single use, Safety scalp vein sets for single use, High-pressure Angiographic syringes and Accessories for single use, Insulin pen needle for single use, Infusion pump for single use, Hollow Fiber Hemodialyzer, Single-use lightproof infusion set, Single-use protective clothing for medical use, Single-use medical surgical face mask, Single-use medical protective face mask, Single- use medical face mask, Single-use Syringe with Catheter tip, Single-use surgical clothing, Single-use sterile dialysis care kit, Single-use enteral feeding infusion set. Design and Development, Production and Sales of In Vitro Diagnostic Consumables (Vacuum Blood Collection Tubes for Single Use).
Valid from	2025-07-01
Valid until	2028-06-30
Revision	05

Manufacturer quality management system certificate held by Jiangxi Hongda Medical Equipment Group Ltd. See both pages for the exact scope and site-specific activities. Validity shown is based on the supplied document; current issuer registry status has not been checked.

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