Reference Source

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

For RESPILON PRODUCTION S.R.O., import alert is 89-08; country is CZECH REPUBLIC; 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)"; 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 listed twice: 10/31/2022 and 08/24/2022; address is Prikop 843/4 , Brno, Jihomoravsky CZECH REPUBLIC, verified against its source on 2026-09-30.

Firm
RESPILON PRODUCTION S.R.O. verified
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
Address
Prikop 843/4 , Brno, Jihomoravsky CZECH REPUBLIC verified
Date published
10/31/2022 verified
08/24/2022 also listed
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 each item verified
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 each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

RESPILON PRODUCTION S.R.O. Date Published : 10/31/2022 Prikop 843/4 , Brno, Jihomoravsky CZECH REPUBLIC

— accessdata.fda.gov, retrieved 2026-09-22

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code and Product

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

— all from accessdata.fda.gov, retrieved 2026-09-22

The same source also states

RESPILON PRODUCTION S.R.O. Date Published : 08/24/2022 Prikop 843/4 , Brno, Jihomoravsky CZECH REPUBLIC

— accessdata.fda.gov, retrieved 2026-09-22

Product code

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: 08/24/2022 Desc: RespiPro 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: 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: 08/24/2022 Desc: RespiPro 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

Source

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

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