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Honor Certificates

Honor Certificates

Our folding disposable facepiece (particulate respirator) has obtained China standard GB2626-2006, European CE standard EN 149:2001+A1:2009 FFP2 level. The medical face mask have obtained European CE standard EN14683: 2019 Type I, Type II and Type IIR level.


Our orthodontic and endodontic products:

  • Compliance with CFDA: Regulations for the Supervision and Administration of Medical Devices in China

  • Certified according to ISO 13485:2012

  • Compliance with USA Regulations for Medical Devices FDA 21 CFR 807

  • CE Certification for the European Union

  • Certified according to Envisa

  • Worldwide registration of our medical devices and products including in Asia. East Europe, Middle East, Central & South America

imd medical honor certificates

IMD Medical Module B EU Type Examination Certificate Annex
IMD Medical Module B EU Type Examination Certificate Annex
Module B EU Type Examination Certificate
Module B EU Type Examination Certificate
EC Certificate
EC Certificate
ModulleB EU Type Examination Certificate
ModulleB EU Type Examination Certificate
IMD Medical Module B EU Type Examination Certificate Annex
IMD Medical Module B EU Type Examination Certificate Annex
TEST REPORT
TEST REPORT
EC Declarafion Of Confonmity
EC Declarafion Of Confonmity
Face Shield EN166 Test Report
Face Shield EN166 Test Report
GIMT Goggles EN166 Test Report
GIMT Goggles EN166 Test Report
ISO 9001 Certificate
ISO 9001 Certificate
Nelson Lab_KN95 Particulate Respirator Filtration Efficiency(NaCl) Test Report
Nelson Lab_KN95 Particulate Respirator Filtration Efficiency(NaCl) Test Report
Sodium Chloride (NaCl) Aerosol Test Final Report
Sodium Chloride (NaCl) Aerosol Test Final Report
Determination Of Inhalation And Exhalation Resistance For Air Purifying Respirators Final Report
Determination Of Inhalation And Exhalation Resistance For Air Purifying Respirators Final Report
PONY Test Report of Disposable Medical Face Mask EN14683 Type I
PONY Test Report of Disposable Medical Face Mask EN14683 Type I
PONY Test Report of Disposable Medical Face Mask EN14683 Type I
PONY Test Report of Disposable Medical Face Mask EN14683 Type I
PONY Test Report of KN95 Respirator
PONY Test Report of KN95 Respirator
PONY Test Report of KN95 Respirator filteration efficiency
PONY Test Report of KN95 Respirator filteration efficiency
PONY Test Report of KN95 Respirator filteration efficiency
PONY Test Report of KN95 Respirator filteration efficiency
PONY Test Report of KN95 Respirator
PONY Test Report of KN95 Respirator
SGS Test Report of Particle Filtering Half Mask FFP2 NR
SGS Test Report of Particle Filtering Half Mask FFP2 NR
Test Report of Disposable Medical Face Mask EN14683 Type II Filteration Efficiency
Test Report of Disposable Medical Face Mask EN14683 Type II Filteration Efficiency
Test Report of Disposable Medical Face Mask EN14683 Type II
Test Report of Disposable Medical Face Mask EN14683 Type II
Test Report of Disposable Medical Face Mask EN14683 Type IIR splash resistance
Test Report of Disposable Medical Face Mask EN14683 Type IIR splash resistance
Test Report of Disposable Medical Face Mask EN14683 Type IIR
Test Report of Disposable Medical Face Mask EN14683 Type IIR