FDA Registration
Active
🇨🇳 China
Changzhou CareU Medical Instruments Co., Ltd.
Reg #: 3015479927
·
FEI: 3015479927
·
Expires 2026
Products
9
Proprietary Names
10
Establishment Types
1
Classifications
9
Research this establishment in seconds
The Research Assistant profiles FDA-registered establishments — listings, owners, related facilities — and cites every record.
Free to try · every answer cites its records
Registration Details
- Registration Name
- Changzhou CareU Medical Instruments Co., Ltd.
- Registration Number
- 3015479927
- FEI Number
- 3015479927
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- No.69 Shunshan Road, Zhenglu Town, Tianning District
- City
- Changzhou City Jiangsu
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K102712
Owner / Operator
- Firm Name
- Changzhou CareU Medical Instruments Co., Ltd
- Operator Number
- 10060446
- Address
- No.69 Shunshan Road, Zhenglu Town, Tianning District
- City
- Changzhou City
- State
- Jiangsu
- Postal Code
- 213000
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- Charles Mack
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Collector, Urine, Pediatric, For Indwelling Catheter | FFH | Class 2 | Gastroenterology, Urology | No | 2024-12-30 |
| Accessory, Surgical Apparel | LYU | Class 1 | General, Plastic Surgery | No | 2020-03-18 |
| Tubes, Gastrointestinal (And Accessories) | KNT | Class 2 | Gastroenterology, Urology | No | 2019-05-13 |
| Collector, Urine, (And Accessories) For Indwelling Catheter | KNX | Class 2 | Gastroenterology, Urology | No | 2019-05-13 |
| Applicator, Absorbent Tipped, Sterile | KXG | Class 1 | General Hospital | No | 2024-12-30 |
| Bag, Urine Collection, Leg, For External Use, Sterile | FAQ | Class 1 | Gastroenterology, Urology | No | 2026-01-19 |
| Paracentesis Tray | PYC | Class 1 | General, Plastic Surgery | No | 2019-12-31 |
| Respirator, Surgical | MSH | Class 2 | General, Plastic Surgery | No | 2020-04-14 |
| Catheter And Tip, Suction | JOL | Class 2 | General Hospital | No | 2024-12-30 |
Proprietary Names
Pediatric Urine Collector
Disposable Non-surgical Mask
Feeding Bag
Plastic Parts
Urine Drainage Bag
Disposable Sampling Swab, Medical Cotton Swab
Leg Bag
Paracentesis Tray
KN95 Mask
Suction Tube
Establishment Types
Manufacture Medical Device