Enskin · 89-08 · KOREA (THE REPUBLIC OF)
For Enskin, import alert is 89-08; country is KOREA (THE REPUBLIC OF); 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 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 2026-09-30.
- 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)
— 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: 10/11/2013 Desc: Skin Stamp 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
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.