Certificates

ISO 13485 Certificate

ISO 14644 CLASS 8 Certificate

Medical device production license by National Medical products administration

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 )

ASTM F2101 VFE Report (Procedure Face Mask)

Passed Skin Sensitisation/ Skin Irritation/ Cytotoxicity Test

Latex Free Report

Particulate Face Mask- FFP2 Report / CE 0598 SGS Finland

US FDA Letter - The Emergency Use Authorization (EUA)

Covid-19 Medical Device Authorisation for importation or sale by Health Canada

Clean Room Report

MHRA Registration Letter