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Quality & Compliance

Certifications Buyers Worldwide Rely On

Every product is manufactured in our ISO 13485:2016-certified facility. Products within the certificate’s scope ship with an EU Declaration of Conformity (DoC); products outside it are supplied OEM / private label, classified per destination market and intended use. Our alcohol prep pads, povidone-iodine prep pads, alcohol swabsticks and povidone-iodine swabsticks are additionally produced under GMP as registered China Class II medical devices.

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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

ISO 13485:2016

QMS for Medical Devices

StandardISO 13485:2016
Certificate no.On request
Issued bySGS United Kingdom Ltd
AccreditationUKAS Management Systems 0005
ScopeManufacture of medical devices
SurveillanceRecertified Dec 2024; annual surveillance
Validity20 Jan 2025 – 17 Jan 2028
Certified since18 Jan 2022
CoveredProduction, QC, CAPA, traceability
Download ISO Certificate

EU Declaration of Conformity

Conformity Documentation

FrameworkEU MDR 2017/745
ScopeProducts within the ISO 13485 certificate scope
EUDAMEDRegistered
Authorised RepJOYSUN GROUP (ES)
Technical FileMaintained & available
PMSActive monitoring
AvailabilityOn request
Request EU DoC

GMP · China Class II

Medical-device GMP & Class II registration

Issuing AuthorityJiangsu Drug Administration
ManufacturingGMP (Class II devices)
Registered scopeAlcohol & iodine prep pads and swabsticks
Registration no.On request
Request Class II / GMP details
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. Compliance verified before dispatch