FDA import alert status
NINGBO BAICHEN MEDICAL DEVICES CO., LTD
China · appears on 2 FDA import alerts
2
Red-list alerts
0
Green-list alerts
China
Country
04/04/2025
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 NINGBO BAICHEN MEDICAL DEVICES CO., LTD?
Put this supplier on watch: we re-check the official FDA import alert list daily and email you the day NINGBO BAICHEN MEDICAL DEVICES 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 89-08RED · 04/04/2025
Detention Without Physical Examination of Devices without Approved PMA's or IDE's and Other Devices Not Substantially Equivalent or Without a 510(k)
- Import Alert 99-49RED · 04/03/2025
Detention Without Physical Examination of Devices Without a Unique Device Identifier and/or Matching GUDID Record
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