Reference Source

West Tech Ltd · 89-08 · HONG KONG SAR

For West Tech Ltd · 89-08 · HONG KONG SAR, 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 HONG KONG SAR; 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 2026-09-16.

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
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

West Tech Ltd Date Published : 12/11/2013 132 Nathan Rd , Kolwoon, HONG KONG SAR 80 M - - QX Needle, Acupuncture, Single Use Date Published: 12/11/2013 Desc: Micro Needle Skin Roller Notes: class II

accessdata.fda.gov, retrieved 2026-09-15

Source

Last verified against source: . Due for re-check by . This page as Markdown · OKF bundle · full dataset as JSON.

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