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