# Shanghai Kindly Enterprise Development Group Co., Ltd · 89-08 · CHINA — FDA import alert red lists: firms subject to detention without physical examination

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: appears in the quote below)_
- **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: appears in the quote below)_
- **Address:** No. 658 Gaochao Road , Jiading, Shanghai CHINA _(verified: appears in the quote below)_
- **Date published:** 08/15/2025 _(verified: appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_
- **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 _(verified: each item appears in the quote below)_

## 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

## Source

- https://www.accessdata.fda.gov/cms_ia/importalert_244.html

Last verified: 2026-09-16. Review by: 2026-11-15.
Part of [FDA import alert red lists: firms subject to detention without physical examination](https://referencesource.org/fda-import-alert-red-list/).