Certification
Certifications
Thorey Gera Textilveredelung GmbH is a certified company according to DIN EN ISO 9001, DIN EN ISO 14001 and EMA with an audited production for medical products based on ISO 13485:2016; EU-GMP guideline 21 CFR 210/211. » www.thotex.de/en
CPA mask | Falt Pandemic
Certification as particle-filtering respirator against corona, SARS-CoV-2, COVID-19
Features
- - CPA - particle filtering protective mask
- - 99,5 % filter performance (only 94 % is prescribed)
- - 100 % Made in Germany
- - 100% recyclable
Standards / Approvals / Tests
- Special approval COVID-19 Coronavirus SARS-CoV-2 according to Rev. 2 of 02.06.2020 according to test report 525/20 of 7.9.2020, Textilforschungsinstitut Thüringen-Vogtland e.V.; EN ISO 10993-5:2009 Biological evaluation of medical devices - Part 5: Testing for in vitro cytotoxicity by the University Hospital Jena Prüfbericht_TITV_525-20.pdf
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Market Surveillance Free State of Thuringia, State Office for Consumer Protection: Bestätigung_CPA_Thorey_110920.pdf
Textile Research Institute Thuringia-Vogtland e.V.: Bewertungsschreiben_525_20_Konformitätserklärung.pdf
Thorey Gera Textilveredelung GmbH: CPA_Maske_Technisches_Merkblatt_09.09.2020.pdf
Thorey Gera Textilveredelung GmbH: Gebrauchsinformation_CPA_Beiblatt_09.09.2020.pdf
FFP2 mask | Falt Basic Plus
Certification as particle filtering respirator, FFP2 NR
Features
- - FFP2 NR* Mask - CE certified
- - particle filtering protective mask
- - 99,5 % filter performance (94 % is mandatory)
- - 100 % Made in Germany
- - 100% recyclable
Standards / Approvals / Tests
CE-certification according to DIN EN 149:2001+A1:2009
Tested and certified in the EU TD11-GT185-FFP2-NR.pdf
- * NR: non reusable
Antiviral FFP2 mask | Falt Med Protect
Certification as particle filtering respirator FFP2 NR with antiviral properties, against corona, SARS-CoV-2, COVID-19
Features
- - FFP2 NR* Mask - CE certified
- - particle filtering protective mask
- - 99,5 % filter performance (94 % is mandatory)
- - 100 % Made in Germany
- - 100% recyclable
Standards / Approvals / Tests
CE-certification according to DIN EN 149:2001+A1:2009
Tested and certified in the EU TD11-GT185-FFP2-NR.pdf
- * NR: non reusable
- ** Confirmation of the antiviral effectiveness of the material of the breathing mask by TU-Ilmenau: https://idw-online.de/de/news744596
