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Honor Certificates

Certificate of honor

Our folding disposable mask (particulate respirator) has Obtained Chinese standard GB2626-2006 and European CE standard EN 149:2001+A1:2009 FFP2 level. Medical mask has been obtained European CE standard EN14683:2019 Class of Type I, Type II and Type IIR.


Our orthodontic and dental pulp products:

  • Comply with CFDA: China's Regulations on the Supervision and Administration of Medical Devices

  • ISO 13485:2012 certified

  • Complies with US medical device regulations FDA 21 CFR 807

  • EU CE certification

  • Certified by Envisa

  • Our medical devices and products are registered worldwide, including in Asia. Eastern Europe, Middle East, Central and South America

imd Medical Honor Certificate

Annex to EU type inspection certificate for IMD medical module B
Module B EU Type Examination Certificate
EC certificate
ModuleB EU Type Examination Certificate
Annex to EU type inspection certificate for IMD medical module B
Test report
EC Declaration of Conformity
Test report of mask EN166
GIMT goggles EN166 test report
ISO 9001 Certificate
Nelson Lab_ Test Report on Filtration Efficiency (NaCl) of KN95 Particulate Breather 11
Final report of sodium chloride (NaCl) aerosol test
Final report on measurement of inhalation and expiratory resistance of air purifying respirators
PONY disposable medical mask EN14683 Type I test report
PONY disposable medical mask EN14683 Type I test report
KN95 Mask PONY Test Report
KN95 respirator filtration efficiency PONY test report
KN95 respirator filtration efficiency PONY test report
KN95 Mask PONY Test Report
Particle filter half mask FFP2 NR SGS test report
Test report on filtration efficiency of disposable medical mask EN14,683 Type II
Test Report of Disposable Medical Mask EN14683 Type II
Test Report on Water Splash Prevention of Disposable Medical Mask EN14683 Type IIR
Test Report of Disposable Medical Mask EN14683 Type IIR