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

For Guangzhou Yuanfan 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 Derma Stamp Electric Pen | Derma Stamp Electric Pen | Derma Stamp Electric Pen; product code is 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 O - - UH Skin resurfacing rf applicator; date published is 03/08/2013; address is Jiefangxi Road 128 , Panyu , Guangzhou City, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Yuanfan 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:** Jiefangxi Road 128 , Panyu , Guangzhou City, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 03/08/2013 _(verified: appears in the quote below)_
- **Product code:** 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 O - - UH Skin resurfacing rf applicator _(verified: each item appears in the quote below)_
- **Product:** Derma Stamp Electric Pen | Derma Stamp Electric Pen | Derma Stamp Electric Pen _(verified: each item appears in the quote below)_
- **FDA notes:** Class II | Class II | class II _(verified: each item appears in the quote below)_

## What the source says

> Guangzhou Yuanfan Co. Ltd Date Published : 03/08/2013 Jiefangxi Road 128 , Panyu , Guangzhou City, Guangdong CHINA 79 G - - ED Brush, Dermabrasion, Manual Date Published: 03/08/2013 Desc: Derma Stamp Electric Pen Notes: Class II 79 G - - FE Brush, Dermabrasion Date Published: 03/08/2013 Desc: Derma Stamp Electric Pen Notes: Class II 79 O - - UH Skin resurfacing rf applicator Date Published: 03/08/2013 Desc: Derma Stamp Electric Pen 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/).