Shenzhen Biocare Bio-Medical Equipment Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 2 device types, 2 products catalogued, 5 clearances.
Shenzhen Biocare Bio-Medical Equipment Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Electrocardiograph, Monitor, Ultrasonic, Fetal. 2 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2011.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3008457078 |
| FEI number | 3008457078 |
| DUNS | 529081176 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳邦健生物医疗设备股份有限公司 |
|---|---|
| Unified social credit code | 91440300279256539X |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | #16-1, Jinhui Road, Jinsha Community |
| Postal code | 518122 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrocardiograph | Class 2 | Digital electrocardiograph, iE 3, iE 6, iE 12, iE 12A, iE 15, ECG-12l0, ECG-3010 and ECG-6010, Digital Electrocardiograph iE 101 and iE300, Digital Electrocardiograph iE 10 | 2015 | 18 |
| Monitor, Ultrasonic, Fetal | Class 2 | FM-200 Doppler Fetal Heart Rate Detector | 2011 | 13 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Digital Electrocardiograph | DPS | 11 |
| Doppler Fetal Heart Rate Detector | KNG | 1 |
Clearances
5 clearances name Shenzhen Biocare Bio-Medical Equipment 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 |
|---|---|---|---|---|
| K160092 | 2016-02-12 | DPS | Special | This company |
| K152384 | 2015-12-18 | DPS | Traditional | This company |
| K141946 | 2015-02-13 | DPS | Traditional | This company |
| K133985 | 2015-01-22 | DPS | Traditional | This company |
| K132758 | 2014-01-30 | DPS | Special | This company |
| K171517 | 2018-01-11 | DPS | Special | Biocare Bio-Medical Equipment Co., Ltd. |
| K100626 | 2010-05-21 | KNG | Traditional | Shenzhen Biocare Electronics Co., Ltd. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | Digital electrocardiographs, Multi-parameter monitors, Fetal monitors, Ultrasound diagnostic devices, Defibrillators, Infusion pumps |
| Certifications | National High-Tech Enterprise, New Third Board Listed (2015) |
| Export markets | 100+ countries |
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.