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Our Certification
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Wellmien has successfully updated the registration and listing information for 2024 with US FDA

Wellmien has obtained CE marking for Product.
Wellmien company has been ISO 13485:2016 certificated.

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Synthetic Blood Penetration Resistance

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Differential Pressure (Delta P)

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Bacterial Filtration Efficiency (BFE)

Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 3

Particle Filtration Efficiency (PFE)
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Synthetic Blood Penetration Resistance
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Differential Pressure (Delta P)
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Bacterial Filtration Efficiency (BFE)
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Particle Filtration Efficiency (PFE)
Test report from Nelson Labs for Wellmien surgical mask ASTM F2100-19 Level 2
Particle Filtration Efficiency (PFE)
Test report from Nelson Labs for Wellmien medical mask EN14683:2019 Type IIR
Synthetic Blood Penetration Resistance
Test report from Nelson Labs for Wellmien medical mask EN14683:2019 TYPE IIR

Bacterial Filtration Efficiency (BFE)
and Differential Pressure (Delta P)

Test report from Nelson Labs for Wellmien medical mask EN14683:2019 TYPE II

Bacterial Filtration Efficiency (BFE)
and Differential Pressure (Delta P)

Wellmien surgical mask was approved by FDA 510K in 2010.
FDA510K number: K101000