# Guangzhou Jian Yuan Electronics Co. Ltd. · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

For Guangzhou Jian Yuan Electronics Co. Ltd. · 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 Micro Needle Skin Roller; product code is 80 M - - QX Needle, Acupuncture, Single Use; date published is 12/11/2013; address is Building No. Floor 6 , 14 Dashi Street; Fanyuindust , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Jian Yuan Electronics Co. Ltd. _(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:** Building No. Floor 6 , 14 Dashi Street; Fanyuindust , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 12/11/2013 _(verified: appears in the quote below)_
- **Product code:** 80 M - - QX Needle, Acupuncture, Single Use _(verified: appears in the quote below)_
- **Product:** Micro Needle Skin Roller _(verified: appears in the quote below)_
- **FDA notes:** class II _(verified: appears in the quote below)_

## What the source says

> Guangzhou Jian Yuan Electronics Co. Ltd. Date Published : 12/11/2013 Building No. Floor 6 , 14 Dashi Street; Fanyuindust , Guangzhou, Guangdong CHINA 80 M - - QX Needle, Acupuncture, Single Use Date Published: 12/11/2013 Desc: Micro Needle Skin Roller Notes: class II

## 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/).