Shanghai Bright Kun Industrial Limited · 89-08 · CHINA
For Shanghai Bright Kun Industrial Limited, 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 Derma Needle Roller | Derma Needle Roller; product code is 79 G - - ED Brush, Dermabrasion, Manual | 89 K - - NM Device, Pressure Applying; date published is 02/14/2017; address is D218 No.168 Jiugan Road , Shanghai, Shanghai CHINA, verified against its source on 2026-09-30.
- Firm
- Shanghai Bright Kun Industrial Limited 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
- D218 No.168 Jiugan Road , Shanghai, Shanghai CHINA verified
- Date published
- 02/14/2017 verified
- Product code
- 79 G - - ED Brush, Dermabrasion, Manual | 89 K - - NM Device, Pressure Applying each item verified
- Product
- Derma Needle Roller | Derma Needle Roller each item verified
- FDA notes
- Class I device without a valid 510k | Class I device without a valid 510k each item verified
What the source says
Shanghai Bright Kun Industrial Limited Date Published : 02/14/2017 D218 No.168 Jiugan Road , Shanghai, Shanghai CHINA
— accessdata.fda.gov, retrieved 2026-09-15
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
79 G - - ED Brush, Dermabrasion, Manual Date Published: 02/14/2017 Desc: Derma Needle Roller Notes: Class I device without a valid 510k 89 K - - NM Device, Pressure Applying Date Published: 02/14/2017 Desc: Derma Needle Roller Notes: Class I device without a valid 510k
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html