DONG RI ELECTRICAL EQUIPMENT COLTD · 89-08 · CHINA
For DONG RI ELECTRICAL EQUIPMENT COLTD, 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 Lumin LM3000 Household Item UV Sanitizer | Lumin LM3000 Household Item Sanitizer and CPAP Accessory Cleaner; 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 2026-09-30.
- Firm
- DONG RI ELECTRICAL EQUIPMENT COLTD 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
- Gaobu Caoduncun , Caodun Industrial Area Gaobuzhen , Dongguan, Guangdong CHINA verified
- Date published
- 06/10/2021 verified
- Product code
- 80 L - - RJ Disinfectant, Medical Devices | 80 L - - RJ Disinfectant, Medical Devices each item verified
- Product
- Lumin LM3000 Household Item UV Sanitizer | Lumin LM3000 Household Item Sanitizer and CPAP Accessory Cleaner each item verified
- 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. each item verified
What the source says
DONG RI ELECTRICAL EQUIPMENT COLTD Date Published : 06/10/2021 Gaobu Caoduncun , Caodun Industrial Area Gaobuzhen , Dongguan, 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, Product and FDA notes
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. 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.
— all from accessdata.fda.gov, retrieved 2026-09-22
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html