FDA import alert
Import Alert 99-49
Detention Without Physical Examination of Devices Without a Unique Device Identifier and/or Matching GUDID Record
6
Red-list entries
0
Green-list entries
2
Countries
2026-06-22
Last change seen
What being on this list means
Firms on an import alert's Red List are subject to Detention Without Physical Examination (DWPE): FDA can detain their shipments at the border automatically, without sampling or inspecting them. The burden shifts to the importer to prove — typically with private laboratory analysis, shipment by shipment — that the goods are not violative. Removal from the list requires evidence that the underlying problem is resolved, usually including a track record of consecutive clean shipments and a petition to FDA. How removal works →
A Green List on a countrywide alert works the other way: it names the firms FDA has excluded from detention because they demonstrated compliance.
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Red-list entries by country
| Country | Entries |
|---|---|
| China | 5 |
| Korea (The Republic Of) | 1 |
Firms on this red list
Showing 6 of 6 entries — search a specific firm on the free checker.
- BRIGHT SUNWAY LIMITED
06/22/2026
China · Massager, Therapeutic, Manual
- HUAGUANG MEDICAL PRODUCTS CO.,LTD.
01/16/2025
China · Glove, Patient Examination, Poly; Glove, Patient Examination, Specialty
- NINGBO BAICHEN MEDICAL DEVICES CO., LTD
04/03/2025
China · Wheelchair, Powered
- Shen Zhen As Tec Technology Co Ltd
07/29/2024
China · Stimulator, Nerve, Transcutaneous, Over-The-Counter; Massager, Therapeutic, Electric; Stimulator, Muscle, Powered, for Muscle Conditioning
- Wuhan Lotuxs Technology Co., Ltd.
08/29/2024
China · Light based over-the-counter hair removal; General Purpose Laser Products, Non-Medical
- MEDITIME CO., LTD
03/26/2024
Korea (The Republic Of) · Suture, Surgical, Absorbable, Polydioxanone
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