Data / Medical devices / China / Changzhou CareU Medical Instruments Co., Ltd.
Changzhou CareU Medical Instruments Co., Ltd.: FDA-registered device maker in Changzhou City Jiangsu, China, 1 510(k) clearance
Changzhou CareU Medical Instruments Co., Ltd. is registered with the FDA (registration 3015479927) in Changzhou City Jiangsu, China. It lists 9 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 2011. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015479927
- Address
- No.69 Shunshan Road, Zhenglu Town, Tianning District, Changzhou City Jiangsu, China, 213000
- Owner or operator
- Changzhou CareU Medical Instruments Co., Ltd (10060446)
- Roles
- Manufacturer
- First device listed
- May 13, 2019
- Registered through
- 2026
- Brand names listed
- Disposable Non-surgical Mask, Disposable Sampling Swab, Medical Cotton Swab, Feeding Bag, KN95 Mask, Leg Bag, Paracentesis Tray, Pediatric Urine Collector, Plastic Parts and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessory, Surgical Apparel | LYU | 1 | Manufacturer | accessdata.fda.gov |
| Applicator, Absorbent Tipped, Sterile | KXG | 1 | Manufacturer | accessdata.fda.gov |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | 1 | Manufacturer | accessdata.fda.gov |
| Catheter And Tip, Suction | JOL | 2 | Manufacturer | accessdata.fda.gov |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | 2 | Manufacturer | accessdata.fda.gov |
| Collector, Urine, Pediatric, For Indwelling Catheter | FFH | 2 | Manufacturer | accessdata.fda.gov |
| Paracentesis Tray | PYC | 1 | Manufacturer | accessdata.fda.gov |
| Respirator, Surgical | MSH | 2 | Manufacturer | accessdata.fda.gov |
| Tubes, Gastrointestinal (And Accessories) | KNT | 2 | 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 |
|---|---|---|---|---|---|---|
| December 16, 2011 | K102712 | MED GRAVITY SET, IMED PUMP SET | KNT | Substantially Equivalent | Imed Technology, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Catheter And Tip, Suction
- All makers of Accessory, Surgical Apparel
- All makers of Respirator, Surgical
- All makers of Applicator, Absorbent Tipped, Sterile
- All makers of Collector, Urine, Pediatric, For Indwelling Catheter
- All makers of Bag, Urine Collection, Leg, For External Use, Sterile
Updated December 16, 2011. 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.