TOPTEC CO. LTD. · 89-08 · KOREA (THE REPUBLIC OF)
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
- 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) 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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.