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