Reference Source

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

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

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