Reference Source

Guangzhou Yuanfan Co. Ltd · 89-08 · CHINA

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
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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

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

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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