Reference Source

Jiangsu Shenli Medical Production Co., Ltd. · 89-08 · CHINA

For Jiangsu Shenli Medical Production 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 All Syringes; product code is 80 F - - MF Syringe, Piston; date published is 03/28/2024; address is No. 20 Changzheng Road , Zhengluzhen Wujin , Changzhou, Jiangsu CHINA, verified against its source on 2026-09-16.

Firm
Jiangsu Shenli Medical Production 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
No. 20 Changzheng Road , Zhengluzhen Wujin , Changzhou, Jiangsu CHINA verified
Date published
03/28/2024 verified
Product code
80 F - - MF Syringe, Piston verified
Product
All Syringes verified
FDA notes
All syringes except luer lock piston syringes size 5 mL (5cc) without color are subject to DWPE under this listing. verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Jiangsu Shenli Medical Production Co., Ltd. Date Published : 03/28/2024 No. 20 Changzheng Road , Zhengluzhen Wujin , Changzhou, Jiangsu CHINA 80 F - - MF Syringe, Piston Date Published: 03/28/2024 Desc: All Syringes Notes: All syringes except luer lock piston syringes size 5 mL (5cc) without color are subject to DWPE under this listing.

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

Source

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