TOPTEC CO. LTD. · 89-08 · KOREA (THE REPUBLIC OF)
For TOPTEC CO. LTD., import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 2026-09-30.
- Firm
- TOPTEC CO. LTD. 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 122 Asanvalley-Ro , Dunpo-Myeon , Asan-Si, CHUNGCHEONGNAMDO KOREA (THE REPUBLIC OF) verified
- Date published
- 03/24/2022 verified
- Product code
- 80 F - - XX Mask, Surgical | 80 F - - XX Mask, Surgical each item verified
- Product
- Air Queen Nano Mask | Nano Mask each item verified
What the source says
TOPTEC CO. LTD. Date Published : 03/24/2022 122 Asanvalley-Ro , Dunpo-Myeon , Asan-Si, CHUNGCHEONGNAMDO KOREA (THE REPUBLIC OF)
— accessdata.fda.gov, retrieved 2026-09-15
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: 03/24/2022 Desc: Air Queen Nano Mask 80 F - - XX Mask, Surgical Date Published: 03/24/2022 Desc: Nano Mask
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html