Well-Life Healthcare Limited · 89-08 · TAIWAN
For Well-Life Healthcare Limited · 89-08 · TAIWAN, 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 TAIWAN; product is Skeen Patch | Skeen Patch; product code is 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 84 G - - XY Electrode, Cutaneous; date published is 08/02/2023; address is Jhonghe District , No. 168, 6 F; Lide St.; Zhonghe Dist. , New Taipei City, TAIWAN, verified against its source on 2026-09-16.
- Firm
- Well-Life Healthcare Limited 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
- TAIWAN verified
- Address
- Jhonghe District , No. 168, 6 F; Lide St.; Zhonghe Dist. , New Taipei City, TAIWAN verified
- Date published
- 08/02/2023 verified
- Product code
- 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. | 84 G - - XY Electrode, Cutaneous each item verified
- Product
- Skeen Patch | Skeen Patch each item verified
What the source says
Well-Life Healthcare Limited Date Published : 08/02/2023 Jhonghe District , No. 168, 6 F; Lide St.; Zhonghe Dist. , New Taipei City, TAIWAN 53 Y - - 99 Other Cosmetic and Cosmetic Products, N.E.C. Date Published: 08/02/2023 Desc: Skeen Patch 84 G - - XY Electrode, Cutaneous Date Published: 08/02/2023 Desc: Skeen Patch
— 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.