Guangzhou Jian Yuan Electronics Co. Ltd. · 89-08 · CHINA
For Guangzhou Jian Yuan Electronics 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 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 2026-09-30.
- 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
— 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
80 M - - QX Needle, Acupuncture, Single Use Date Published: 12/11/2013 Desc: Micro Needle Skin Roller 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