Data / Medical devices / China / Clinisupplies (nanjing) Co., Ltd
Clinisupplies (nanjing) Co., Ltd: FDA-registered device maker in Nanjing Jiangsu, China, 2 510(k) clearances
Clinisupplies (nanjing) Co., Ltd is registered with the FDA (registration 3014195785) in Nanjing Jiangsu, China. It lists 13 device types. The FDA files 2 510(k) clearances under its listings, the newest dated July 27, 2017. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014195785
- Address
- 86-8 Shuanggao Road Gaochun, Nanjing Jiangsu, China, 211316
- Owner or operator
- Vitalcare Trading (UK) Ltd. (10057056)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- February 15, 2018
- Registered through
- 2026
- Brand names listed
- Aquaflush, Fetal Pillow, GB Night Bag, Jiffy Cath, Libra Leg Bag-sterile, Libra Sheath, N95 Surgical Respirator, Nelaton Catheter and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bag, Urine Collection, Leg, For External Use, Non-Sterile | NNW | 1 | Contract manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Contract manufacturer | accessdata.fda.gov |
| Catheter, Urological | KOD | 2 | Contract manufacturer | accessdata.fda.gov |
| Device, Incontinence, Urosheath Type, Non-Sterile | NNX | 1 | Contract manufacturer | accessdata.fda.gov |
| Dressing, Wound, Occlusive | NAD | 1 | Exporter to the US | accessdata.fda.gov |
| Enema Kit | FCE | 1 | Manufacturer | accessdata.fda.gov |
| Fetal Head Elevator | PWB | 2 | Exporter to the US | accessdata.fda.gov |
| Instrument, Manual, General Obstetric-Gynecologic | KOH | 1 | Exporter to the US | accessdata.fda.gov |
| Irrigator, Ostomy | EXD | 2 | Manufacturer | accessdata.fda.gov |
| Protector, Ostomy | EXE | 1 | Exporter to the US | accessdata.fda.gov |
| Rectal Insert | PBP | 2 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Exporter to the US | accessdata.fda.gov |
| Urinary Drainage Collection Kit, For Indwelling Catheter | FCN | 2 | Contract manufacturer, Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| July 27, 2017 | DEN150053 | FETAL PILLOW | PWB | Unknown | Safe Obstetric Systems, Ltd. | accessdata.fda.gov |
| October 26, 2012 | K122003 | RENEW INSERT | PBP | Substantially Equivalent | Renew Medical, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Respirator, Surgical
- All makers of Catheter, Urological
- All makers of Protector, Ostomy
- All makers of Irrigator, Ostomy
Updated July 27, 2017. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.