Data / Medical devices / China / Shenzhen Coreray Technology Co., Ltd.
Shenzhen Coreray Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 4 510(k) clearances
Shenzhen Coreray Technology Co., Ltd. is registered with the FDA (registration 3014233600) in Shenzhen Guangdong, China. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated September 23, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014233600
- Address
- Chuangzhi Industrial Building, No.1 Yingai Road Langkou Community, Dalang Street, Longhua District, Shenzhen Guangdong, China, 518109
- Owner or operator
- Shenzhen Coreray Technology Co., Ltd. (10056465)
- Roles
- Manufacturer
- First device listed
- December 12, 2017
- Registered through
- 2026
- Brand names listed
- ECG Cable/Leadwires, ECG Electrode, Flexible Video Laryngoscope CR-33/ CR-33D/ CR-33R/ CR-33DR/ CR-33P/ CR-33U/ CR-33DU/ CR-33C/ CR-33DC/ CR-33DCH/ CR-33DH, Flexible Video Laryngoscope CR-33VD, Nasal Oxygen Cannula, Patient Monitoring Cable (SpO2 Extension Cable), Reusable NIBP Cuff, SpO2 Sensor and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Manufacturer | accessdata.fda.gov |
| Cable, Transducer And Electrode, Patient, (Including Connector) | DSA | 2 | Manufacturer | accessdata.fda.gov |
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Electrode, Electrocardiograph | DRX | 2 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Non-Rigid | CAL | 1 | Manufacturer | accessdata.fda.gov |
| Laryngoscope, Rigid | CCW | 1 | Manufacturer | accessdata.fda.gov |
| Otoscope | ERA | 1 | Manufacturer | accessdata.fda.gov |
| Oximeter | DQA | 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 |
|---|---|---|---|---|---|---|
| September 23, 2021 | K211747 | Reusable NIBP Cuff | DXQ | Substantially Equivalent | Shenzhen Coreray Technology Co., Ltd. | accessdata.fda.gov |
| June 22, 2020 | K192404 | Patient Monitoring Cable (SpO2 Extension Cable) | DSA | Substantially Equivalent | Shenzhen Coreray Technology, Ltd. | accessdata.fda.gov |
| August 31, 2018 | K173368 | Reusable & Disposable SpO2 Sensors | DQA | Substantially Equivalent | Shenzhen Coreray Technology, Ltd. | accessdata.fda.gov |
| February 28, 2018 | K172797 | ECG Cable/Leadwires | DSA | Substantially Equivalent | Shenzhen Coreray Technology, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Laryngoscope, Rigid
- All makers of Cable, Transducer And Electrode, Patient, (Including Connector)
- All makers of Oximeter
- All makers of Blood Pressure Cuff
- All makers of Laryngoscope, Non-Rigid
- All makers of Otoscope
Updated September 23, 2021. 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.