Mask supply

Our Chinese partners have also given us the opportunity to obtain significant quantities of high quality masks, 3-ply type for surgical use (Class I – Type I and II), certified, at particularly attractive prices.

3-ply surgical (Type I)

Certifications

Attestation of Conformity Relevant EC Directive: Classification (MDR, Annex VIII): Class I, Rule 1. Conformity Assessment Route: EU DECLARATION OF CONFORMITY following the Annex II + Annex III + Article 19 of MDR (EU) 2017/745.

Applied Quality Management System: EN ISO 13485/2016: Compliance with domestic certificate, class I type II Disposable Medical Face Mask.

Business of Medical Device License Code: 91330400676192794L

Manufacture Certificate code of : ***** 20200075

Registration of Manufacture Disposable Medical Face Mask: **** 20202141113

Applied normative documents:

EN14683:2019 Technical Description of the mask (as required by EN 14683:2019):

Bacterial Filtration Efficiency BFE: EN14683:2019 > 99%

Particulate Filtration Efficiency PFE: 97%-99% NIOSH Procedure No. RCT-APR-STP-0059

Bio-burden: Passed Compliance YY/T0969 GB 15979-2002 ANNEX-B

Differential pressure (transspirability): Passed Compliance YY/T0969 5.6

Labeling, packaging, end user instructions: Compliance ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labeling and information

Compliance with to ISO 10993-1:2009/COR 1:2010 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.

3-ply surgical (Type II)

Packaging

Certifications

Attestation of Conformity Relevant EC Directive: Classification (MDR, Annex VIII): Class I, Rule 1. Conformity Assessment Route: EU DECLARATION OF CONFORMITY following the Annex II + Annex III + Article 19 of MDR (EU) 2017/745.

Applied Quality Management System: EN ISO 13485/2016: Compliance with domestic certificate, class I type II Disposable Medical Face Mask.

Business of Medical Device License Code: 91330400676192794L

Manufacture Certificate code of : ***** 20200075

Registration of Manufacture Disposable Medical Face Mask: **** 20202141113

Applied normative documents:

EN14683:2019 Technical Description of the mask (as required by EN 14683:2019):

Bacterial Filtration Efficiency BFE: EN14683:2019 > 99%

Particulate Filtration Efficiency PFE: 97%-99% NIOSH Procedure No. RCT-APR-STP-0059

Bio-burden: Passed Compliance YY/T0969 GB 15979-2002 ANNEX-B

Differential pressure (transspirability): Passed Compliance YY/T0969 5.6

Labeling, packaging, end user instructions: Compliance ISO 15223-1, Medical devices — Symbols to be used with medical device labels, labeling and information

Compliance with to ISO 10993-1:2009/COR 1:2010 Biological evaluation of medical devices — Part 1: Evaluation and testing within a risk management process.

For any information, do not hesitate to contact us at covid19@yodhresearch.com