FDA Registration
Active
🇨🇳 China
SHENZHEN CORERAY TECHNOLOGY CO., LTD.
Reg #: 3014233600
·
FEI: 3014233600
·
Expires 2026
Products
8
Proprietary Names
11
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- SHENZHEN CORERAY TECHNOLOGY CO., LTD.
- Registration Number
- 3014233600
- FEI Number
- 3014233600
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 803-804 Chuangzhi Industrial Building, No.1 Yingai Road, Langkou Community, Dalang Street, Longhua District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K192404
Owner / Operator
- Firm Name
- Shenzhen Coreray Technology Co., Ltd.
- Operator Number
- 10056465
- Address
- 803-804 Chuangzhi Industrial Building, No.1 Yingai Ro, Langkou Community, Dalang Street, Longhua District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518109
- Country
- CN
- Correspondent
- SIMON FAN
US Agent
- Business Name
- GRZAN GROUP INC.
- Contact Name
- Andy Smith
- Address
- 8825 53 AVE
- City
- Elmhurst
- State
- NY
- ZIP
- 11373
- Country
- US
- [email protected]
- Phone
- 332 2015192
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Electrode, Electrocardiograph | DRX | Class 2 | Cardiovascular | No | 2017-12-12 |
| Laryngoscope, Non-Rigid | CAL | Class 1 | Anesthesiology | No | 2018-12-04 |
| Otoscope | ERA | Class 1 | Ear, Nose, Throat | No | 2020-11-24 |
| Cannula, Nasal, Oxygen | CAT | Class 1 | Anesthesiology | No | 2019-10-25 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | Class 2 | Cardiovascular | No | 2020-06-29 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2021-09-23 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-09-21 |
| Laryngoscope, Rigid | CCW | Class 1 | Anesthesiology | No | 2018-12-04 |
Proprietary Names
ECG Electrode
Flexible Video Laryngoscope CR-33/ CR-33D/ CR-33H/ CR-33HD/ CR-33CHD
Flexible Video Laryngoscope CR-33R/ CR-33RD/ CR-33HR/ CR-33P/ CR-33U/ CR-33UD/ CR-33HU/ CR-33C/ CR-33CD/ CR-33HC
Video Otorhinolaryngoscope CR-31O
Nasal Oxygen Cannula
Patient Monitoring Cable (SpO2 Extension Cable)
ECG Cable/Leadwires
Reusable NIBP Cuff
SpO2 Sensor
Video Oto-Laryngoscope CR-31O
Video Laryngoscope CR-31/ CR-31T/ CR-31V/ CR-31D/ CR-32/ CR-VLS-A/ CR-VLS-P/ CR-AMW
Establishment Types
Manufacture Medical Device