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

For Guangzhou Wadami Beauty Equipment 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 (Body) Roller | Derma (Body) Roller | Derma (Body) Roller | Derma (Body) Roller; product code is 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - EF Applier, Staple, Surgical | 79 M - - DM Instrument, Manual, General Surgical | 89 L - - YG Massager, Therapeutic, Manual; date published is 10/03/2013; address is 330 Guangcong First Road , Baiyun Dist , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.

- **Firm:** Guangzhou Wadami Beauty Equipment 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:** 330 Guangcong First Road , Baiyun Dist , Guangzhou, Guangdong CHINA _(verified: appears in the quote below)_
- **Date published:** 10/03/2013 _(verified: appears in the quote below)_
- **Product code:** 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - EF Applier, Staple, Surgical | 79 M - - DM Instrument, Manual, General Surgical | 89 L - - YG Massager, Therapeutic, Manual _(verified: each item appears in the quote below)_
- **Product:** Derma (Body) Roller | Derma (Body) Roller | Derma (Body) Roller | Derma (Body) Roller _(verified: each item appears in the quote below)_
- **FDA notes:** Class II Device | Class II Device | CLASS II Device | Class II Device _(verified: each item appears in the quote below)_

## What the source says

> Guangzhou Wadami Beauty Equipment Co Ltd Date Published : 10/03/2013 330 Guangcong First Road , Baiyun Dist , Guangzhou, Guangdong CHINA 79 G - - ED Brush, Dermabrasion, Manual Date Published: 10/03/2013 Desc: Derma (Body) Roller Notes: Class II Device 79 G - - EF Applier, Staple, Surgical Date Published: 10/03/2013 Desc: Derma (Body) Roller Notes: Class II Device 79 M - - DM Instrument, Manual, General Surgical Date Published: 10/03/2013 Desc: Derma (Body) Roller Notes: CLASS II Device 89 L - - YG Massager, Therapeutic, Manual Date Published: 10/03/2013 Desc: Derma (Body) Roller Notes: Class II Device

## 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/).