Leel Tech · 89-08 · CHINA

For Leel Tech · 89-08 · CHINA, 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 CHINA; product is LEEL CPAP Cleaner; all models | SOLID CPAP Cleaner (Solid CPAP & ONECLICK SOLID models) | CLYN CPAP Cleaner (CZ001 & CLYN Universal models); product code is 80 Q - - XQ Respiratory accessory microbial reduction device. | 80 Q - - XQ Respiratory accessory microbial reduction device. | 80 Q - - XQ Respiratory accessory microbial reduction device; date published is 02/20/2026; address is 9c-9, Xiangyuntiandu Century Building Xinzhou , 3rd Street, Futian District , Shenzhen, Guangdong CHINA, verified against its source on 2026-09-16.

What the source says

Leel Tech Date Published : 02/20/2026 9c-9, Xiangyuntiandu Century Building Xinzhou , 3rd Street, Futian District , Shenzhen, Guangdong CHINA 80 Q - - XQ Respiratory accessory microbial reduction device. Date Published: 02/20/2026 Desc: LEEL CPAP Cleaner; all models 80 Q - - XQ Respiratory accessory microbial reduction device. Date Published: 02/20/2026 Desc: SOLID CPAP Cleaner (Solid CPAP & ONECLICK SOLID models) 80 Q - - XQ Respiratory accessory microbial reduction device. Date Published: 02/20/2026 Desc: CLYN CPAP Cleaner (CZ001 & CLYN Universal models)

— accessdata.fda.gov, retrieved 2026-09-15

Source

• accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified against source: 2026-09-16. Due for re-check by 2026-11-15. This page as Markdown · OKF bundle · full dataset as JSON.