# DONG RI ELECTRICAL EQUIPMENT COLTD · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For DONG RI ELECTRICAL EQUIPMENT COLTD · 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 Lumin LM3000 Household Item Sanitizer and CPAP Accessory Cleaner | Lumin LM3000 Household Item UV Sanitizer; product code is 80 L - - RJ Disinfectant, Medical Devices | 80 L - - RJ Disinfectant, Medical Devices; date published is 06/10/2021; address is Gaobu Caoduncun , Caodun Industrial Area Gaobuzhen , Dongguan, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** DONG RI ELECTRICAL EQUIPMENT COLTD _(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:** Gaobu Caoduncun , Caodun Industrial Area Gaobuzhen , Dongguan, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 06/10/2021 _(verified: appears in the quote below)_
- **Product code:** 80 L - - RJ Disinfectant, Medical Devices | 80 L - - RJ Disinfectant, Medical Devices _(verified: each item appears in the quote below)_
- **Product:** Lumin LM3000 Household Item Sanitizer and CPAP Accessory Cleaner | Lumin LM3000 Household Item UV Sanitizer _(verified: each item appears in the quote below)_
- **FDA notes:** Providing 510(k) may not be sufficient to overcome the appearance of violation. | Providing 510(k) may not be sufficient to overcome the appearance of violation. _(verified: each item appears in the quote below)_

## What the source says

> DONG RI ELECTRICAL EQUIPMENT COLTD Date Published : 06/10/2021 Gaobu Caoduncun , Caodun Industrial Area Gaobuzhen , Dongguan, Guangdong CHINA 80 L - - RJ Disinfectant, Medical Devices Date Published: 06/10/2021 Desc: Lumin LM3000 Household Item Sanitizer and CPAP Accessory Cleaner Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation. 80 L - - RJ Disinfectant, Medical Devices Date Published: 06/10/2021 Desc: Lumin LM3000 Household Item UV Sanitizer Notes: Providing 510(k) may not be sufficient to overcome the appearance of violation.

## 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/).