Changzhou CareU Medical Instruments Co., Ltd.
Registered establishment in Changzhou, Jiangsu, China. 9 device types.
Changzhou CareU Medical Instruments Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Paracentesis Tray, Respirator, Surgical and 7 other device types. Its earliest product listing with the FDA dates from 2019.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3015479927 |
| FEI number | 3015479927 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 常州市凯优医疗器械有限公司 |
|---|---|
| Source | customs registration record |
Location
| City | Changzhou |
|---|---|
| Province | Jiangsu |
| Address | No.69 Shunshan Road, Zhenglu Town, Tianning District |
| Postal code | 213000 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | Disposable Non-surgical Mask | 2020 | 439 |
| Applicator, Absorbent Tipped, Sterile | Class 1 | Disposable Sampling Swab, Medical Cotton Swab | 2024 | 100 |
| Bag, Urine Collection, Leg, For External Use, Sterile | Class 1 | Leg Bag | 2026 | 52 |
| Catheter And Tip, Suction | Class 2 | Suction Tube | 2024 | 70 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | Class 2 | Plastic Parts, Urine Drainage Bag | 2019 | 51 |
| Collector, Urine, Pediatric, For Indwelling Catheter | Class 2 | Pediatric Urine Collector | 2024 | 11 |
| Paracentesis Tray | Class 1 | Paracentesis Tray | 2019 | 1 |
| Respirator, Surgical | Class 2 | KN95 Mask | 2020 | 118 |
| Tubes, Gastrointestinal (And Accessories) | Class 2 | Feeding Bag | 2019 | 25 |
Clearances
No clearance names Changzhou CareU Medical Instruments Co., Ltd. as applicant. One is held by another company 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 |
|---|---|---|---|---|
| K102712 | 2011-12-16 | KNT | Traditional | Imed Technology, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2017 |
|---|---|
| Main products | Feeding bags, Urine bags, Medical components, Cervical brushes, Face coverings |
| Certifications | ISO, CE, FDA, GOST, FFP2NR |
| Export markets | Russia, EU |
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.