Reference Source

NINGBO HANYUE MEDICAL TECHNOLOGYCO.,LTD · 89-08 · CHINA

For NINGBO HANYUE MEDICAL TECHNOLOGYCO.,LTD · 89-08 · CHINA, 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 CHINA; product is Anti-choke Rescue Devices | Anti-choke Rescue Devices | Anti-choke Rescue Devices; product code is 73 B - - SY Catheters, Suction, Tracheobronchial | 77 E - - WT Device, Antichoke, Suction | 80 G - - CX Apparatus, Suction, Operating-Room, Wall Vacuum Powered; date published is 08/18/2025; address is No.58 Yugong Road , Cixi City, CHINA, verified against its source on 2026-09-16.

Firm
NINGBO HANYUE MEDICAL TECHNOLOGYCO.,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
CHINA verified
Address
No.58 Yugong Road , Cixi City, CHINA verified
Date published
08/18/2025 verified
Product code
73 B - - SY Catheters, Suction, Tracheobronchial | 77 E - - WT Device, Antichoke, Suction | 80 G - - CX Apparatus, Suction, Operating-Room, Wall Vacuum Powered each item verified
Product
Anti-choke Rescue Devices | Anti-choke Rescue Devices | Anti-choke Rescue Devices each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

NINGBO HANYUE MEDICAL TECHNOLOGYCO.,LTD Date Published : 08/18/2025 No.58 Yugong Road , Cixi City, CHINA 73 B - - SY Catheters, Suction, Tracheobronchial Date Published: 08/18/2025 Desc: Anti-choke Rescue Devices 77 E - - WT Device, Antichoke, Suction Date Published: 08/18/2025 Desc: Anti-choke Rescue Devices 80 G - - CX Apparatus, Suction, Operating-Room, Wall Vacuum Powered Date Published: 08/18/2025 Desc: Anti-choke Rescue Devices

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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