Wellmien Certifications | Trusted Quality and Compliance

Our Certification

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Introduction

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Wellmien Healthcare Suzhou FDA 2026.pdf

Wellmien has successfully updated the registration and listing information for 2026 with US FDA

ISO 13485.pdf

Wellmien company has been ISO 13485:2016 certificated.

CERT-Wellmien
Healthcare.pdf

Wellmien has obtained CE marking for Product.

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 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 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 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 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 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 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 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 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 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 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)

Wellmien surgical mask was approved by FDA 510K in 2010.

FDA510K number: K101000

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