Shenzhen Coreray Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 8 device types, 5 products catalogued, 4 clearances.
Shenzhen Coreray Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Otoscope, Oximeter and 6 other device types. 5 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2017.
8device types registered with the FDA
5products catalogued under its own name
4510(k) clearances
Registration
| Registered name | SHENZHEN CORERAY TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014233600 |
| FEI number | 3014233600 |
| DUNS | 544519750 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市科睿特医疗器械有限公司 |
|---|---|
| Source | Baidu Baike |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 803-804 Chuangzhi Industrial Building, No.1 Yingai Road |
| Postal code | 518109 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Blood Pressure Cuff | Class 2 | Reusable NIBP Cuff | 2021 | 50 |
| Cable, Transducer And Electrode, Patient, (Including Connector) | Class 2 | Patient Monitoring Cable (SpO2 Extension Cable), ECG Cable/Leadwires | 2018 | 22 |
| Cannula, Nasal, Oxygen | Class 1 | Nasal Oxygen Cannula | 2019 | 97 |
| Electrode, Electrocardiograph | Class 2 | ECG Electrode | 2017 | 33 |
| Laryngoscope, Non-Rigid | Class 1 | 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 | 2018 | 12 |
| Laryngoscope, Rigid | Class 1 | Video Laryngoscope CR-31/ CR-31T/ CR-31V/ CR-31D/ CR-32/ CR-32D/CR-VLS-A/ CR-VLS-P/ CR-AMW, Video Oto-Laryngoscope CR-31O | 2018 | 44 |
| Otoscope | Class 1 | Video Otorhinolaryngoscope CR-31O | 2020 | 43 |
| Oximeter | Class 2 | SpO2 Sensor | 2018 | 70 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| coreray ECG cable | DSA | 3 |
| Aile | DXQ | 1 |
| coreray reusable SpO2 sensor | DQA | 1 |
| Patient Monitoring Cable (SpO2 Extension Cable) | DSA | 1 |
| coreray EKG cable | DSA | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K211747 | 2021-09-23 | DXQ | Traditional | This company |
| K192404 | 2020-06-22 | DSA | Traditional | This company |
| K173368 | 2018-08-31 | DQA | Traditional | This company |
| K172797 | 2018-02-28 | DSA | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Factory area | 5,000-20,000 m² |
| Main products | Endoscopes, Airway management equipment, Urology equipment, ENT equipment, Veterinary equipment |
| Certifications | FDA, ISO 13485, CE |
| Export markets | 140+ countries: Europe, USA, Middle East, South America, Africa |
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.
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