Enskin · 89-08 · KOREA (THE REPUBLIC OF)
For Enskin · 89-08 · KOREA (THE REPUBLIC OF), 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 KOREA (THE REPUBLIC OF); product is Skin Stamp; product code is 80 M - - QX Needle, Acupuncture, Single Use; date published is 10/11/2013; address is 210 C-Dong, 145 Bundang Techo Park , Sungnam, Gyeonggi KOREA (THE REPUBLIC OF), verified against its source on 2026-09-16.
- Firm
- Enskin 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
- KOREA (THE REPUBLIC OF) verified
- Address
- 210 C-Dong, 145 Bundang Techo Park , Sungnam, Gyeonggi KOREA (THE REPUBLIC OF) verified
- Date published
- 10/11/2013 verified
- Product code
- 80 M - - QX Needle, Acupuncture, Single Use verified
- Product
- Skin Stamp verified
- FDA notes
- Class II verified
What the source says
Enskin Date Published : 10/11/2013 210 C-Dong, 145 Bundang Techo Park , Sungnam, Gyeonggi KOREA (THE REPUBLIC OF) 80 M - - QX Needle, Acupuncture, Single Use Date Published: 10/11/2013 Desc: Skin Stamp 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.