Reference Source

Devon Medical Products (Jianagsu) Ltd. · 89-08 · CHINA

For Devon Medical Products (Jianagsu) Ltd., import alert is 89-08; country is CHINA; 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)"; product is ExtriCare 3600 Negative Pressure Wound Therapy Device; product code is 79 O - - MP Negative pressure wound therapy powered suction pump; date published is 11/01/2021; address is East Half Of 1-2f, Appt D2, Qinfeng , High; Zhuxingzhen Chongchuan District , Nantong, Jiangsu CHINA, verified against its source on 2026-09-30.

Firm
Devon Medical Products (Jianagsu) 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
East Half Of 1-2f, Appt D2, Qinfeng , High; Zhuxingzhen Chongchuan District , Nantong, Jiangsu CHINA verified
Date published
11/01/2021 verified
Product code
79 O - - MP Negative pressure wound therapy powered suction pump verified
Product
ExtriCare 3600 Negative Pressure Wound Therapy Device verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Devon Medical Products (Jianagsu) Ltd. Date Published : 11/01/2021 East Half Of 1-2f, Appt D2, Qinfeng , High; Zhuxingzhen Chongchuan District , Nantong, Jiangsu CHINA

— accessdata.fda.gov, retrieved 2026-09-15

Where each value comes from

The values above are stated away from the sentence quoted with the answer, so the passage that states them is shown here too.

Product code and Product

79 O - - MP Negative pressure wound therapy powered suction pump Date Published: 11/01/2021 Desc: ExtriCare 3600 Negative Pressure Wound Therapy Device

— all from 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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