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Certificates

ISO 13485 Certificate

ISO_13485-A5

ISO 14644 CLASS 8 Certificate

ASTM F2100 Report (Procedure Face Mask) BFE/ Delta P

ASTM F2100 PFE Result  

ASTM F2100 Synthetic Blood Penetration

(Passed Level 2 standard)

ASTM F2100 Synthetic Blood Penetration

(Passed Level 3 standard)

EN 14683 Report(Procedure Face Mask/ Passed Type II/ IIR standard )

EN_14683_Report p1

EN_14683_Report p2

ASTM F2101 VFE Report (Procedure Face Mask)

ASTM F2101_VFE_Report_STC

Passed Skin Sensitisation/ Skin Irritation/ Cytotoxicity Test

Latex Free Report

Latex_Free_STC-01

Particulate Face Mask- FFP2 Report / CE 0598 SGS Finland

US FDA Letter - The Emergency Use Authorization (EUA)

Clean Room Report

YY-0033-2000_Clean Room Report

MHRA Registration Letter

MHRA Registration Letter