China Qingdao Bright Medical Manufacturing Co., Ltd.
Manufacturer and brand owner in Qingdao, Shandong, China. 8 device types, 1 product catalogued.
China Qingdao Bright Medical Manufacturing Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Cable, Electrode, Electrode, Cutaneous and 6 other device types. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2008.
Registration
| Registered name | CHINA QINGDAO BRIGHT MEDICAL MANUFACTURING CO.,LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007048259 |
| FEI number | 3007048259 |
| DUNS | 529138313 |
| Establishment type | Contract manufacturer, Manufacturer, Exporter |
Location
| City | Qingdao |
|---|---|
| Province | Shandong |
| Address | No.1 Tiankang Road |
| Postal code | 266107 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cable, Electrode | Class 2 | Qingdao Brgiht | 2008 | 47 |
| Device, Vein Location, Liquid Crystal | Class 1 | Qingdao Brgiht | 2013 | 10 |
| Electrode, Cutaneous | Class 2 | BRAINSTREAM Disposable Deep Cup EEG Electrodes | 2020 | 47 |
| Electrode, Electrocardiograph | Class 2 | Electrode.Electrocardiograph 40494E – Limb Clamp Electrode | 2014 | 33 |
| Electrode, Electrocardiograph, Multi-Function | Class 2 | Gel Electrode | 2018 | 6 |
| System, Monitoring, Perinatal | Class 2 | OB-Tools Ltd. | 2016 | 6 |
| Tester, Electrode/Lead, Electroencephalograph | Class 1 | Qingdao Brgiht | 2015 | 2 |
| Uterine Electromyographic Monitor | Class 2 | OB-Tools Ltd. | 2016 | 1 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Qingdao Bright | MLN | 1 |
Clearances
No clearance names China Qingdao Bright Medical Manufacturing Co., Ltd. as applicant. 2 are held by other companies and named on this establishment’s own product listings: the device is cleared under that company’s 510(k) and listed under this registration.
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K200540 | 2020-06-01 | GXY | Traditional | ConMed Corporation |
| K150398 | 2015-08-06 | HGM | Traditional | Ob Tools, Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1993 |
|---|---|
| Main products | ECG human-machine interfaces, EEG/EMG human-machine interfaces, sleep respiratory monitoring systems, medical wearable electrode sensors, medical vein illuminators |
| Certifications | EU CE, US FDA, Japanese Foreign Manufacturer Certification, Russian Quality certification |
| Export markets | Global with 500+ medical companies and research institutes |
| OEM and ODM | Offered |
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.
The manufacturer named here can complete this record.