Shenzhen Hingmed Medical Instrument Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 1 device type, 1 product catalogued, 3 clearances.
Shenzhen Hingmed Medical Instrument Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers System, Measurement, Blood-Pressure, Non-Invasive. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2026.
Registration
| Registered name | SHENZHEN HINGMED MEDICAL INSTRUMENT CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3043047278 |
| FEI number | 3043047278 |
| DUNS | 421349271 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳星脉医疗仪器有限公司 |
|---|---|
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 4th Floor, Zhonghangfeixiang Building, NO. 371 |
| Postal code | 518102 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | Wearable Ambulatory Blood Pressure Monitor (WBP-02A), Clinical Automatic Blood Pressure Monitor (DBP-20, DBP-20i), Clinical Automatic Blood Pressure Monitor (DBP-01P, DBP-01HP) | 2026 | 98 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Hingmed | DXN | 5 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K251581 | 2026-02-13 | DXN | Traditional | This company |
| K251307 | 2026-01-12 | DXN | Traditional | This company |
| K231984 | 2024-03-26 | DXN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | ambulatory blood pressure monitors, blood pressure monitors, non-invasive ventilators |
| Certifications | ISO 13485, CE, FDA 510K, UKCA |
| Export markets | France, Italy, Thailand, Ethiopia, UK, Spain, Poland, Southeast Asia |
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.