Leel Tech · 89-08 · CHINA
For Leel Tech, import alert is 89-08; country is CHINA; 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 LEEL CPAP Cleaner; all models | CLYN CPAP Cleaner (CZ001 & CLYN Universal models) | SOLID CPAP Cleaner (Solid CPAP & ONECLICK SOLID 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 2026-09-30.
- Firm
- Leel Tech 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
- CHINA verified
- Address
- 9c-9, Xiangyuntiandu Century Building Xinzhou , 3rd Street, Futian District , Shenzhen, Guangdong CHINA verified
- Date published
- 02/20/2026 verified
- Product code
- 80 Q - - XQ Respiratory accessory microbial reduction device. | 80 Q - - XQ Respiratory accessory microbial reduction device. | 80 Q - - XQ Respiratory accessory microbial reduction device. each item verified
- Product
- LEEL CPAP Cleaner; all models | CLYN CPAP Cleaner (CZ001 & CLYN Universal models) | SOLID CPAP Cleaner (Solid CPAP & ONECLICK SOLID models) each item verified
What the source says
Leel Tech Date Published : 02/20/2026 9c-9, Xiangyuntiandu Century Building Xinzhou , 3rd Street, Futian District , Shenzhen, Guangdong CHINA
— 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 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: CLYN CPAP Cleaner (CZ001 & CLYN Universal models) 80 Q - - XQ Respiratory accessory microbial reduction device. Date Published: 02/20/2026 Desc: SOLID CPAP Cleaner (Solid CPAP & ONECLICK SOLID models)
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html