# Leel Tech · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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.

- **Firm:** Leel Tech _(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:** CHINA _(verified: appears in the quote below)_
- **Address:** 9c-9, Xiangyuntiandu Century Building Xinzhou , 3rd Street, Futian District , Shenzhen, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 02/20/2026 _(verified: appears in the quote below)_
- **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. _(verified: each item appears in the quote below)_
- **Product:** LEEL CPAP Cleaner; all models | SOLID CPAP Cleaner (Solid CPAP & ONECLICK SOLID models) | CLYN CPAP Cleaner (CZ001 & CLYN Universal models) _(verified: each item appears in the quote below)_

## 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)

## 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/).