FDA Registration
Active
🇨🇳 China
FOSHAN KYCARE MEDICAL EQUIPMENT CO. LTD
Reg #: 3033859527
·
FEI: 3033859527
·
Expires 2026
Products
3
Proprietary Names
6
Establishment Types
4
Classifications
3
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Registration Details
- Registration Name
- FOSHAN KYCARE MEDICAL EQUIPMENT CO. LTD
- Registration Number
- 3033859527
- FEI Number
- 3033859527
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Room 401, Building 29, Liandong Yougu Park, No. 3 Dongsan District, Jiansha Road, Danzao Town, Nanhai District
- City
- Foshan City Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K251607
Owner / Operator
- Firm Name
- Foshan KYCARE Medical Equipment Co. Ltd
- Operator Number
- 10091799
- Address
- Room 401, Building 29, Liandong Yougu Park, No. 3 Dongsan District, Jiansha Road, Danzao Town, Nanhai District
- City
- Foshan City
- State
- Guangdong
- Postal Code
- 528000
- Country
- CN
- Correspondent
- Leona Zhou
US Agent
- Business Name
- SHARE INFO INC.
- Contact Name
- Clare Ho
- Address
- 3557 158th St Flushing, NY 11358, USA
- City
- Flushing
- State
- NY
- ZIP
- 11358
- Country
- US
- [email protected]
- Phone
- 929 4102964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Generator, Oxygen, Portable | CAW | Class 2 | Anesthesiology | No | 2025-11-25 |
| Flowmeter, Calibration, Gas | BXY | Class 1 | Anesthesiology | No | 2024-11-02 |
| Flowmeter, Tube, Thorpe, Back-Pressure Compensated | CAX | Class 1 | Anesthesiology | No | 2024-11-02 |
Proprietary Names
Oxygen Concentrator (J5A)
ZY5BA Oxygen Concentrator
Oxygen Concentrator (Model: J10A)
KYCARE J10A OXYGEN CONCENTRATOR
Flowmeter
Firestop Cannula Valve
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device
Manufacture Medical Device for Another Party (Contract Manufacturer)
Complaint File Establishment per 21 CFR 820.198