Guangzhou Wadami Beauty Equipment Co Ltd · 89-08 · CHINA
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
- 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
- 330 Guangcong First Road , Baiyun Dist , Guangzhou, Guangdong CHINA verified
- Date published
- 10/03/2013 verified
- 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 each item verified
- Product
- Derma (Body) Roller | Derma (Body) Roller | Derma (Body) Roller | Derma (Body) Roller each item verified
- FDA notes
- Class II Device | Class II Device | CLASS II Device | Class II Device each item verified
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
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html