RESPILON PRODUCTION S.R.O. · 89-08 · CZECH REPUBLIC

For RESPILON PRODUCTION S.R.O. · 89-08 · CZECH REPUBLIC, import alert is 89-08; import alert name is "Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)"; country is CZECH REPUBLIC; product is Self Sterilizing FFP2 Nano Respirator | Self Sterilizing FFP2 Nano Respirator | Self Sterilizing FFP2 Nano Respirator | Self Sterilizing FFP2 Nano Respirator | Self Sterilizing FFP2 Nano Respirator | Self Sterilizing FFP2 Nano Respirator; product code is 80 F - - XX Mask, Surgical | 80 M - - SH Respirator, surgical | 80 N - - ZJ Respirator, n95, home use | 80 Q - - KR Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance | 80 Q - - KU Non-NIOSH-approved Disposable Filtering Facepiece Respirators (FFRs) | 80 Q - - OZ Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Publ; date published is 10/31/2022; address is Prikop 843/4 , Brno, Jihomoravsky CZECH REPUBLIC, verified against its source on 2026-09-16.

What the source says

RESPILON PRODUCTION S.R.O. Date Published : 10/31/2022 Prikop 843/4 , Brno, Jihomoravsky CZECH REPUBLIC 80 F - - XX Mask, Surgical Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 M - - SH Respirator, surgical Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 N - - ZJ Respirator, n95, home use Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 Q - - KR Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 Q - - KU Non-NIOSH-approved Disposable Filtering Facepiece Respirators (FFRs) Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 Q - - OZ Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Publ Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator

— accessdata.fda.gov, retrieved 2026-09-15

The same source also states

RESPILON PRODUCTION S.R.O. Date Published : 08/24/2022 Prikop 843/4 , Brno, Jihomoravsky CZECH REPUBLIC 80 F - - XX Mask, Surgical Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 M - - SH Respirator, surgical Date Published: 08/24/2022 Desc: RespiPro Respirator 80 M - - SH Respirator, surgical Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 N - - ZJ Respirator, n95, home use Date Published: 08/24/2022 Desc: RespiPro Respirator 80 N - - ZJ Respirator, n95, home use Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 Q - - KR Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 Q - - KR Face mask (except N95 respirator) for general public/healthcare personnel per IIE guidance Date Published: 08/24/2022 Desc: RespiPro Respirator 80 Q - - KU Non-NIOSH-approved Disposable Filtering Facepiece Respirators (FFRs) Date Published: 08/24/2022 Desc: RespiPro Respirator 80 Q - - KU Non-NIOSH-approved Disposable Filtering Facepiece Respirators (FFRs) Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 Q - - OZ Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Publ Date Published: 10/31/2022 Desc: Self Sterilizing FFP2 Nano Respirator 80 Q - - OZ Barrier Face Covering Per Enforcement Policy For Face Masks And Respirators During The Covid-19 Publ Date Published: 08/24/2022 Desc: RespiPro Respirator

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.