Quality Manageament System
Wellmein has built a quality management system for the product process at every stage, to make sure all the products comform to the Standard.
Wellmein has built a quality management system for the product process at every stage, to make sure all the products comform to the Standard.
Receiving Materials
Inspecting Materials
Storing Materials
Feeding Materials
Folding
Welding and Cutting
Ear Band Welding
Inspection
Inner Bag Coding
Box Coding
Packaging
Product Inspection
Storing Finished Goods
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Wellmian Healthcare Suzhou FDA 2023.pdf | Wellmien has successfully updated the registration and listing information for 2023 with US FDA |
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CERT-Wellmien Healthcare.pdf | Wellmien has obtained CE marking for Product. |
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ISO 13485.pdf | Wellmien company has been ISO 13485:2016 certificated. |
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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 |
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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) |
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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) |
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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) |
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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 |
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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) |
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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) |
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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) |
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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 |
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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) |
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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) |
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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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