Our Certification

Our Certification

Picture Name Introduction Download
Wellmian Healthcare Suzhou FDA 2022.pdf Wellmian Healthcare Suzhou FDA 2022.pdf Wellmien has successfully updated the registration and listing information for 2022 with US FDA
CERT-Wellmien Healthcare.pdf CERT-Wellmien Healthcare.pdf Wellmien has obtained CE marking for Product.
ISO 13485.pdf ISO 13485.pdf Wellmien company has been ISO 13485:2016 certificated.
Test Report for SBP Resistance of ASTM Leve 3 surgical mask Test Report for SBP Resistance of ASTM Leve 3 surgical mask Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Synthetic Blood Penetration Resistance
Test Report for Delta P of ASTM Leve 3 surgical mask Test Report for Delta P of ASTM Leve 3 surgical mask Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Differential Pressure (Delta P)
Test Report for BFE of ASTM Leve 3 surgical mask Test Report for BFE of ASTM Leve 3 surgical mask Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Bacterial Filtration Efficiency (BFE)
Test Report for PFE of ASTM Leve 3 surgical mask Test Report for PFE of ASTM Leve 3 surgical mask Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Particle Filtration Efficiency (PFE)
Test Report for SBP Resistance of ASTM Leve 2 surgical mask Test Report for SBP Resistance of ASTM Leve 2 surgical mask Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2

Synthetic Blood Penetration Resistance
Test Report for Delta P of ASTM Leve 2 surgical mask Test Report for Delta P of ASTM Leve 2 surgical mask Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2

Differential Pressure (Delta P)
Test Report for BFE of ASTM Leve 2 surgical mask Test Report for BFE of ASTM Leve 2 surgical mask Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2

Bacterial Filtration Efficiency (BFE)
Test Report for PFE of ASTM Leve 2 surgical mask Test Report for PFE of ASTM Leve 2 surgical mask Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2

Particle Filtration Efficiency (PFE)
Test Report for SBP Resistance of Type IIR Mask Test Report for SBP Resistance of Type IIR Mask Test report from Nelson Labs for Wellmien medical mask EN14683:2019 Type IIR

Synthetic Blood Penetration Resistance
Test Report for BFE&Delta P of TYPE IIR mask Test Report for BFE&Delta P of TYPE IIR mask Test report from Nelson Labs for Wellmien medical mask EN14683:2019 TYPE IIR

Bacterial Filtration Efficiency (BFE)
and Differential Pressure (Delta P)
Test Report for BFE&Delta P of TYPE II mask Test Report for BFE&Delta P of TYPE II mask Test report from Nelson Labs for Wellmien medical mask EN14683:2019 TYPE II

Bacterial Filtration Efficiency (BFE)
and Differential Pressure (Delta P)
FDA 510K for Wellmien Surgical Mask (No. K101000) FDA 510K for Wellmien Surgical Mask (No. K101000) Wellmien surgical mask was approved by FDA 510K in 2010.

FDA510K number: K101000
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