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Quality & Compliance

Certifications That EU Buyers Rely On

Every product is made under ISO 13485:2016, holds a China Class II medical device license, and ships with an EU Declaration of Conformity, everything your procurement and regulatory team needs.

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ISO 13485:2016

Quality System

China Class II

Mfg License

Original Certificates

Verified Certificates You Can Inspect

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EU Declaration of Conformity
EU Declaration of ConformityView full size →
ISO 13485:2016 Certificate
ISO 13485:2016 CertificateView full size →
Certification Details

Our Compliance Portfolio

China Class II

Medical Device License & Registration

Alcohol Pad Reg.苏械注准 20162141079
Iodine Swab Reg.苏械注准 20172141057
Issuing AuthorityJiangsu Drug Admin.
Mfg LicenseClass II Medical Device
Iodine Pad / Alcohol SwabReg. no. on request
Request Class II Details

ISO 13485:2016

QMS for Medical Devices

StandardISO 13485:2016
ScopeDesign, manufacture & QC
SurveillanceAnnual, passed 2025
Validity3-year cycle
CoveredDesign, production, CAPA
Download ISO Certificate

EU Declaration of Conformity

Conformity Documentation

FrameworkEU MDR 2017/745
ScopeAll products
EUDAMEDCN-MF-000047617
Authorised RepJOYSUN GROUP (ES)
Technical FileMaintained & available
PMSActive monitoring
AvailabilityOn request
Request EU DoC
Our Quality Process

How We Ensure Every Batch Meets Standards

1

Raw Material QC

All incoming materials tested for spec compliance before production begins

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2

In-Process Control

Continuous monitoring of IPA concentration, fabric weight, and packaging integrity

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3

Finished Product Testing

Each batch tested: kill rates, liquid content, seal integrity, dimensions

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4

Documentation & Release

Full batch record, COA, shipping docs. CE compliance verified before dispatch