Biox Instruments Co Ltd
Registered establishment in Wuxi, Jiangsu, China. 2 device types.
Biox Instruments Co Ltd is a manufacturer holding a current FDA establishment registration. The registration covers Recorder, Magnetic Tape, Medical, System, Measurement, Blood-Pressure, Non-Invasive. Its earliest product listing with the FDA dates from 2009.
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3007663004 |
| FEI number | 3007663004 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 无锡市中健科仪有限公司 |
|---|---|
| Unified social credit code | 913202112405023848 |
| Source | NMPA UDI database |
Location
| City | Wuxi |
|---|---|
| Province | Jiangsu |
| Address | 100 Dicui Road, 530 Building 1, 19th Floor |
| Postal code | 214072 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Recorder, Magnetic Tape, Medical | Class 2 | Vasomedical-Biox 2301 ABPECG Record, ARCS, Model 1305, ARCS, Biox, Models 1303, 1304, 1306,1307,1308, ARCS, Models 1804, 1805, 1806, 1807, 2302, 2303, 2304, 2305, 2306, ARCS | 2009 | 4 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Vasomedical-Biox 2301 ABPECG Record, ARCS, Models 1804, 1805, 1806, 1807, 2302, 2303, 2304, 2305, 2306, ARCS | 2010 | 98 |
Clearances
No clearance names Biox Instruments Co Ltd as applicant. 4 are held by another company 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 |
|---|---|---|---|---|
| K111180 | 2011-06-28 | DSH | Special | Vasomedical, Inc. |
| K111096 | 2011-06-24 | DSH | Special | Vasomedical, Inc. |
| K092785 | 2010-04-02 | DSH | Traditional | Vasomedical, Inc. |
| K083820 | 2009-04-01 | DSH | Traditional | Vasomedical, Inc. |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 1996 |
|---|---|
| Main products | dynamic ECG, dynamic blood pressure monitoring, multi-parameter monitoring equipment |
| Certifications | ISO 9001, ISO 13485, FDA, CE, Canadian CMDCAS, Brazilian ANVISA |
| Export markets | International (FDA, CE, Canada, Brazil certifications) |
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.