West Tech Ltd · 89-08 · HONG KONG SAR
For West Tech Ltd, import alert is 89-08; country is HONG KONG SAR; 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 132 Nathan Rd , Kolwoon, HONG KONG SAR, verified against its source on 2026-09-30.
- Firm
- West Tech 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
- HONG KONG SAR verified
- Address
- 132 Nathan Rd , Kolwoon, HONG KONG SAR 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
West Tech Ltd Date Published : 12/11/2013 132 Nathan Rd , Kolwoon, HONG KONG SAR
— 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
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.