Jiangsu Shenli Medical Production Co., Ltd. · 89-08 · CHINA
For Jiangsu Shenli Medical Production Co., 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 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 2026-09-30.
- 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
What the source says
Jiangsu Shenli Medical Production Co., Ltd. Date Published : 03/28/2024 No. 20 Changzheng Road , Zhengluzhen Wujin , Changzhou, 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, Product and FDA notes
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.
— all from accessdata.fda.gov, retrieved 2026-09-15
Source
- accessdata.fda.govhttps://www.accessdata.fda.gov/cms_ia/importalert_244.html
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