Reference Source

Guangzhou Hua Nan Medical Apparatus & Instruments Co., Ltd. · 89-08 · CHINA

For Guangzhou Hua Nan Medical Apparatus & Instruments Co., 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 Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices; product code is 89 - - - -- Physical Medicine; date published is 01/23/2019; address is 212 Xingang W. Road , Guangzhou, CHINA, verified against its source on 2026-09-16.

Firm
Guangzhou Hua Nan Medical Apparatus & Instruments Co., 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
212 Xingang W. Road , Guangzhou, CHINA verified
Date published
01/23/2019 verified
Product code
89 - - - -- Physical Medicine verified
Product
Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices verified
FDA notes
2/24/1998 verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Guangzhou Hua Nan Medical Apparatus & Instruments Co., Ltd. Date Published : 01/23/2019 212 Xingang W. Road , Guangzhou, CHINA 89 - - - -- Physical Medicine Date Published: 01/23/2019 Desc: Positive/Negative Pressure Integrated Computer Control Augmented Sequential External Counter-Pulsation Devices Notes: 2/24/1998

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

Source

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