Quality & documentation

Clear information.
Informed decisions.

Request documentation matched to your product, model and destination market.

DOCUMENTATION THAT FITS

The right documents
for the right product.

Product requirements vary by model, application and destination.

When discussing your project, tell us the product or model and the documents your team needs to review. Technical specifications, available product instructions and supporting certificates can then be matched to the inquiry.

Certificate scope, holder and validity should always be reviewed for the specific product under consideration.

Request product documents

CERTIFICATES & FILES

Explore available documents.

SUPPLIER & PRODUCT DOCUMENTATION

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

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
Scope: 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.
Valid until: 2028-06-30

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.

View details Open document

SUPPLIER & PRODUCT DOCUMENTATION

ISO 9001:2015 Quality Management System – Jiangxi Hongda

Holder: Jiangxi Hongda Medical Equipment Group Ltd.
Standard: GB/T 19001-2016 / ISO 9001:2015
Reference: 05325Q30290R1M
Scope: Quality management system for the licensed single-use medical consumables listed on the certificate, including injection, infusion, catheter, dialysis, examination and protective products.
Valid until: 2028-05-20

Manufacturer certificate held by Jiangxi Hongda Medical Equipment Group Ltd. Scope is limited to the products and activities listed in the source document. Validity shown is based on the supplied document; current issuer registry status has not been checked.

View details Open document

YOUR SOURCING STARTS HERE

Start with your product and destination.

Let’s discuss the specification and documentation your team needs to review.

Request a quote

Clear information.Informed decisions.

The right documentsfor the right product.