FDA import alert status
ONETECH MEDICAL EQUIPMENT CO LIM
China · appears on 2 FDA import alerts
2
Red-list alerts
0
Green-list alerts
China
Country
08/07/2017
Last entry seen
What this means
As published on the official FDA import alert list, this firm appears on 2 red lists. A red-list firm is subject to Detention Without Physical Examination (DWPE): FDA can detain its shipments at the border automatically, without sampling. The burden shifts to the importer to prove the goods are not violative.
Import alert status changes over time. Import Alert Radar re-checks the official FDA source every day; the entries below reflect the latest refresh (2026-07-21 UTC).
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Red-list entries
- Import Alert 89-08RED · 08/07/2017
Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)
- Import Alert 95-05RED · 07/31/2017
Detention Without Physical Examination of Electronic Products that Fail to Comply with Performance Standards or to Have Required Certification
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