Reference Source

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

For Shanghai Kindly Enterprise Development Group 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 Oral/Enteral Syringe | Sterile Syringe Bulk Tray | Sterile Safety Syringes for Single Use | KDL Safety Needles | Sterile Safety Syringes for Single Use | KDL Disposable Infusion Set | Sterile Syringe Bulk Tray | Sterile Safety Syringes for Single Use (Retractable) | Sterile Safety Syringes for Single Use | Sterile Safety Insulin Syringes for Single Use; 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 2026-09-16.

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 Syringe Bulk Tray | Sterile Safety Syringes for Single Use | KDL Safety Needles | Sterile Safety Syringes for Single Use | KDL Disposable Infusion Set | Sterile Syringe Bulk Tray | Sterile Safety Syringes for Single Use (Retractable) | Sterile Safety Syringes for Single Use | Sterile Safety Insulin Syringes for Single Use each item verified
FDA notes
Oral/Enteral Syringe | Sterile Syringe Bulk Tray | Sterile Safety Syringes for Single Use | KDL Safety Needles | Sterile Safety Syringes for Single Use | KDL Disposable Infusion Set | Sterile Syringe Bulk Tray | Sterile Safety Syringes for Single Use (Retractable) | Sterile Safety Syringes for Single Use | Sterile Safety Insulin Syringes for Single Use 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 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 Syringe Bulk Tray Notes: Sterile Syringe Bulk Tray 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 - - 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 Syringe Bulk Tray Notes: Sterile Syringe Bulk Tray 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 Syringes for Single Use Notes: Sterile Safety Syringes for Single Use 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

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

Source

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