# Shanghai Bright Kun Industrial Limited · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Shanghai Bright Kun Industrial Limited · 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 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 2026-09-16.

- **Firm:** Shanghai Bright Kun Industrial Limited _(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:** D218 No.168 Jiugan Road , Shanghai, Shanghai CHINA _(verified: appears in the quote below)_
- **Date published:** 02/14/2017 _(verified: appears in the quote below)_
- **Product code:** 79 G - - ED Brush, Dermabrasion, Manual | 89 K - - NM Device, Pressure Applying _(verified: each item appears in the quote below)_
- **Product:** Derma Needle Roller | Derma Needle Roller _(verified: each item appears in the quote below)_
- **FDA notes:** Class I device without a valid 510k | Class I device without a valid 510k _(verified: each item appears in the quote below)_

## What the source says

> Shanghai Bright Kun Industrial Limited Date Published : 02/14/2017 D218 No.168 Jiugan Road , Shanghai, Shanghai CHINA 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

## 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/).