Certificate No. 60139108

Certificate Number: 60139108
Certificate Holder: Xiantao Zhongtai Protective
Products Co., Ltd.
3#, Taizi Lake Industry Park
Pengchang Town, Xiantao City
433018 Hubei Province
China (Mainland)
Scope:

Manufacture and Distribution of Medical Devices
(see attachment for products included)
Products:
Surgical Gowns, Face Masks, Surgical Drapes, Surgical
Lab Coats, Coveralls, Shoe Covers, Aprons, Pillow Covers,
Drape Packs, Surgical Caps, Isolation Gowns, Patient Gowns,
Examination Sheets, Snood Covers, Sleeve Covers, Beard
Covers

Fulfilled Standards: EN ISO 13485:2016
Certificate Type: QMS

Quality Management System
EN ISO13485 quality management standard for medical devices and related services

The European standard EN ISO 13485 specifies requirements for a quality management system when an organization is required to demonstrate its ability to provide medical devices and related services that constantly meet customer requirements and applicable legal requirements.

Competent auditors analyze and evaluate the customer's quality management system. If all applicable requirements are met, its quality management system is certified according to EN ISO 13485.

The customer's quality management system is subject to regular monitoring.

Certified customers may use the test mark in their communication.

Further information on this service can be found here.