# RESPILON PRODUCTION S.R.O. · 89-08 · CZECH REPUBLIC — FDA import alert red lists: firms subject to detention without physical examination

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.

- **Firm:** RESPILON PRODUCTION S.R.O. _(verified: appears in the quote below)_
- **Import alert:** 89-08
- **Import alert name:** "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:** CZECH REPUBLIC _(verified: appears in the quote below)_
- **Address:** Prikop 843/4 , Brno, Jihomoravsky CZECH REPUBLIC _(verified: appears in the quote below)_
- **Date published:** 10/31/2022 _(verified: appears in the quote below)_
- **Product code:** 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 _(verified: each item appears in the quote below)_
- **Product:** 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 _(verified: each item appears in the quote below)_

## 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

## 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

Source: https://www.accessdata.fda.gov/cms_ia/importalert_244.html

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).