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 

FFP2 mask | Falt Basic Plus

Certification as particle filtering half mask, FFP2 NR

Certification as particle filtering half mask FFP2 NR D with additional dust protection (dolomite dust)

Features

  • - FFP2 NR* Mask - CE certified
  • - particle filtering half mask
  • - 99,5 % filter performance (94 % is mandatory)
  • - 100 % Made in Germany
  • - 100% recyclable

  • *NR: non reusable

Standards / Approvals / Tests

CE-certification according to DIN EN 149:2001+A1:2009
Tested and certified in the EU: pdfTD11-GT185-FFP2_NR_D_X1_s.pdf

pdfEU_declaration_of_conformity_Thorey_CE_Falt_Basic_Plus_NR_D_application.pdf

pdfDeclaration of clearance_basic_plus.pd

Quality assurance according to module C2:

pdfED29-E098-X1_2021.12.31_s.pdf  

pdfED29-E097-E098_2021.12.31_s.pdf


» REQUEST A QUOTE

 

 

Antiviral FFP2 mask | Falt Med Protect

Certification as particle filtering half mask 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

*NR: non reusable
** Confirmation of the antiviral effectiveness of the material of the breathing mask by TU-Ilmenau: https://idw-online.de/de/news744596

Standards / Approvals / Tests

CE-certification according to DIN EN 149:2001+A1:2009
Tested and certified in the EU: pdfTD11-GT184-FFP2-1.pdf

pdfEU_declaration_of_conformity_Thorey_CE_Falt_Med_Protect_application.pdf

pdfDeclaration of clearance_med_protect.pdf

Quality assurance according to module C2:

pdfED29-E097-E098_2021.12.31_s.pdf


» REQUEST A QUOTE