# TOPTEC CO. LTD. · 89-08 · KOREA (THE REPUBLIC OF) — FDA import alert red lists: firms subject to detention without physical examination

For TOPTEC CO. LTD. · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Air Queen Nano Mask | Nano Mask; product code is 80 F - - XX Mask, Surgical | 80 F - - XX Mask, Surgical; date published is 03/24/2022; address is 122 Asanvalley-Ro , Dunpo-Myeon , Asan-Si, CHUNGCHEONGNAMDO KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.

- **Firm:** TOPTEC CO. LTD. _(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:** KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Address:** 122 Asanvalley-Ro , Dunpo-Myeon , Asan-Si, CHUNGCHEONGNAMDO KOREA (THE REPUBLIC OF) _(verified: appears in the quote below)_
- **Date published:** 03/24/2022 _(verified: appears in the quote below)_
- **Product code:** 80 F - - XX Mask, Surgical | 80 F - - XX Mask, Surgical _(verified: each item appears in the quote below)_
- **Product:** Air Queen Nano Mask | Nano Mask _(verified: each item appears in the quote below)_

## What the source says

> TOPTEC CO. LTD. Date Published : 03/24/2022 122 Asanvalley-Ro , Dunpo-Myeon , Asan-Si, CHUNGCHEONGNAMDO KOREA (THE REPUBLIC OF) 80 F - - XX Mask, Surgical Date Published: 03/24/2022 Desc: Air Queen Nano Mask 80 F - - XX Mask, Surgical Date Published: 03/24/2022 Desc: Nano Mask

## 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/).