Guangzhou Jian Yuan Electronics Co. Ltd. · 89-08 · CHINA
For Guangzhou Jian Yuan Electronics 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 Micro Needle Skin Roller; product code is 80 M - - QX Needle, Acupuncture, Single Use; date published is 12/11/2013; address is Building No. Floor 6 , 14 Dashi Street; Fanyuindust , Guangzhou, Guangdong CHINA, verified against its source on 2026-09-16.
- Firm
- Guangzhou Jian Yuan Electronics 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
- Building No. Floor 6 , 14 Dashi Street; Fanyuindust , Guangzhou, Guangdong CHINA verified
- Date published
- 12/11/2013 verified
- Product code
- 80 M - - QX Needle, Acupuncture, Single Use verified
- Product
- Micro Needle Skin Roller verified
- FDA notes
- class II verified
What the source says
Guangzhou Jian Yuan Electronics Co. Ltd. Date Published : 12/11/2013 Building No. Floor 6 , 14 Dashi Street; Fanyuindust , Guangzhou, Guangdong CHINA 80 M - - QX Needle, Acupuncture, Single Use Date Published: 12/11/2013 Desc: Micro Needle Skin Roller Notes: class II
— accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
This one changes, and we watch it.FDA import alert red lists: firms subject to detention without physical examination is re-read on a schedule and every change is dated. Subscribe: Atom feed · JSON · what has changed so far.