Guangzhou Yuanfan Co. Ltd · 89-08 · CHINA
For Guangzhou Yuanfan 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 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 2026-09-30.
- Firm
- Guangzhou Yuanfan 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
- Jiefangxi Road 128 , Panyu , Guangzhou City, Guangdong CHINA verified
- Date published
- 03/08/2013 verified
- Product code
- 79 G - - ED Brush, Dermabrasion, Manual | 79 G - - FE Brush, Dermabrasion | 79 O - - UH Skin resurfacing rf applicator each item verified
- Product
- Derma Stamp Electric Pen | Derma Stamp Electric Pen | Derma Stamp Electric Pen each item verified
- FDA notes
- Class II | Class II | class II each item verified
What the source says
Guangzhou Yuanfan Co. Ltd Date Published : 03/08/2013 Jiefangxi Road 128 , Panyu , Guangzhou City, 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: 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
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html