DONG RI ELECTRICAL EQUIPMENT COLTD · 89-08 · CHINA
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
- 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 Sanitizer and CPAP Accessory Cleaner | Lumin LM3000 Household Item UV Sanitizer 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 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.
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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