Reference Source

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

For Devon Medical Products (Jianagsu) 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 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 2026-09-16.

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

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

Source

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