Reference Source

Shanghai Kindly Enterprise Development Group Co., Ltd · 89-08 · CHINA

For Shanghai Kindly Enterprise Development Group 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 Oral/Enteral Syringe | Sterile Safety Syringes for Single Use | Sterile Syringe Bulk Tray | KDL Safety Needles | Sterile Safety Syringes for Single Use | KDL Disposable Infusion Set | Sterile Safety Syringes for Single Use (Retractable) | Sterile Safety Insulin Syringes for Single Use | Sterile Safety Syringes for Single Use | Sterile Syringe Bulk Tray; product code is 78 P - - NR Enteral Syringes with enteral specific connectors | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - PA Set, Administration, Intravascular | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick; date published is 08/15/2025; address is No. 658 Gaochao Road , Jiading, Shanghai CHINA, verified against its source on 2026-09-30.

Firm
Shanghai Kindly Enterprise Development Group 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. 658 Gaochao Road , Jiading, Shanghai CHINA verified
Date published
08/15/2025 verified
Product code
78 P - - NR Enteral Syringes with enteral specific connectors | 80 F - - MF Syringe, Piston | 80 F - - MF Syringe, Piston | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - MI Needle, Hypodermic, Single Lumen | 80 F - - PA Set, Administration, Intravascular | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick | 80 M - - EG Syringe, Antistick each item verified
Product
Oral/Enteral Syringe | Sterile Safety Syringes for Single Use | Sterile Syringe Bulk Tray | KDL Safety Needles | Sterile Safety Syringes for Single Use | KDL Disposable Infusion Set | Sterile Safety Syringes for Single Use (Retractable) | Sterile Safety Insulin Syringes for Single Use | Sterile Safety Syringes for Single Use | Sterile Syringe Bulk Tray each item verified
FDA notes
Oral/Enteral Syringe | Sterile Safety Syringes for Single Use | Sterile Syringe Bulk Tray | KDL Safety Needles | Sterile Safety Syringes for Single Use | KDL Disposable Infusion Set | Sterile Safety Syringes for Single Use (Retractable) | Sterile Safety Insulin Syringes for Single Use | Sterile Safety Syringes for Single Use | Sterile Syringe Bulk Tray each item verified
Sourceaccessdata.fda.gov
Verified
Review by
DatasetFDA import alert red lists: firms subject to detention without physical examination

What the source says

Shanghai Kindly Enterprise Development Group Co., Ltd Date Published : 08/15/2025 No. 658 Gaochao Road , Jiading, Shanghai CHINA

— accessdata.fda.gov, retrieved 2026-09-22

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

78 P - - NR Enteral Syringes with enteral specific connectors Date Published: 08/15/2025 Desc: Oral/Enteral Syringe Notes: Oral/Enteral Syringe 80 F - - MF Syringe, Piston Date Published: 08/15/2025 Desc: Sterile Safety Syringes for Single Use Notes: Sterile Safety Syringes for Single Use 80 F - - MF Syringe, Piston Date Published: 08/15/2025 Desc: Sterile Syringe Bulk Tray Notes: Sterile Syringe Bulk Tray 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 08/15/2025 Desc: KDL Safety Needles Notes: KDL Safety Needles 80 F - - MI Needle, Hypodermic, Single Lumen Date Published: 08/15/2025 Desc: Sterile Safety Syringes for Single Use Notes: Sterile Safety Syringes for Single Use 80 F - - PA Set, Administration, Intravascular Date Published: 08/15/2025 Desc: KDL Disposable Infusion Set Notes: KDL Disposable Infusion Set 80 M - - EG Syringe, Antistick Date Published: 08/15/2025 Desc: Sterile Safety Syringes for Single Use (Retractable) Notes: Sterile Safety Syringes for Single Use (Retractable) 80 M - - EG Syringe, Antistick Date Published: 08/15/2025 Desc: Sterile Safety Insulin Syringes for Single Use Notes: Sterile Safety Insulin Syringes for Single Use 80 M - - EG Syringe, Antistick Date Published: 08/15/2025 Desc: Sterile Safety Syringes for Single Use Notes: Sterile Safety Syringes for Single Use 80 M - - EG Syringe, Antistick Date Published: 08/15/2025 Desc: Sterile Syringe Bulk Tray Notes: Sterile Syringe Bulk Tray

— all from accessdata.fda.gov, retrieved 2026-09-22

Source

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