Guangzhou Wadami Beauty Equipment Co Ltd · 89-08 · CHINA
For Guangzhou Wadami Beauty Equipment Co Ltd, import alert is 89-08; country is CHINA; 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)"; 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 2026-09-30.
- 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
— accessdata.fda.gov, retrieved 2026-09-15
Where each value comes from
The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.
Product code, Product and FDA notes
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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html