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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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