Clinisupplies (Nanjing) Co., Ltd.
Registered establishment in Nanjing, Jiangsu, China. 13 device types.
Clinisupplies (Nanjing) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Enema Kit, Rectal Insert and 11 other device types. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | CLINISUPPLIES (NANJING) CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014195785 |
| FEI number | 3014195785 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 美国海关记录适用于此业务及所有其他工厂 |
|---|---|
| Source | ImportGenius customs records |
Location
| City | Nanjing |
|---|---|
| Province | Jiangsu |
| Address | 86-8 Shuanggao Road |
| Postal code | 211316 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | Class 1 | GB Night Bag | 2025 | 47 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Libra Leg Bag-sterile | 2025 | 52 |
| Catheter, Urological | Class 2 | Nelaton Catheter, Jiffy Cath | 2021 | 9 |
| Device, Incontinence, Urosheath Type, Non-Sterile | Class 1 | Libra Sheath | 2025 | 13 |
| Dressing, Wound, Occlusive | Class 1 | Aquaflush | 2019 | 183 |
| Enema Kit | Class 1 | Aquaflush | 2019 | 24 |
| Fetal Head Elevator | Class 2 | Fetal Pillow | 2018 | 1 |
| Instrument, Manual, General Obstetric-Gynecologic | Class 1 | POP Ruler | 2021 | 8 |
| Irrigator, Ostomy | Class 2 | Aquaflush | 2019 | 2 |
| Protector, Ostomy | Class 1 | Aquaflush | 2019 | 33 |
| Rectal Insert | Class 2 | Renew Insert | 2025 | 1 |
| Respirator, Surgical | Class 2 | N95 Surgical Respirator | 2020 | 118 |
| Urinary Drainage Collection Kit, For Indwelling Catheter | Class 2 | VitalCare, Libra Leg Bag-sterile | 2019 | 11 |
Clearances
No clearance names Clinisupplies (Nanjing) Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| DEN150053 | 2017-07-27 | PWB | Direct | Safe Obstetric Systems, Ltd. |
| K122003 | 2012-10-26 | PBP | Traditional | Renew Group Private Limited |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.