FDA import alert status
Contec Medical Systems Co., Ltd.
China · appears on 2 FDA import alerts
2
Red-list alerts
0
Green-list alerts
China
Country
10/02/2025
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).
Do you buy from Contec Medical Systems Co., Ltd.?
Put this supplier on watch: we re-check the official FDA import alert list daily and email you the day Contec Medical Systems Co., Ltd. is added to a red list — or removed from one — so a detained shipment never catches you by surprise.
Red-list entries
- Import Alert 89-04RED · 10/02/2025
Detention Without Physical Examination of Devices from Firms that Have not met Device Quality System Requirements
- Import Alert 89-08RED · 01/24/2025
Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)
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