Ortus Medi-Tech Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 2 device types.
Ortus Medi-Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Tourniquet, Pneumatic, Syringe, Balloon Inflation, Exempt. Its earliest product listing with the FDA dates from 2024.
Registration
| Registered name | ORTUS MEDI-TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3033773618 |
| FEI number | 3033773618 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳宜心康健科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 203, Building C4, Tong Fu Yu lndustrial Park, FuPing Road, Ping Di, Longgang |
| Postal code | 518117 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Syringe, Balloon Inflation, Exempt | Class 2 | Ortus, Disposable Inflation Device, OM-ID-0120, OM-ID-0220, OM-ID-0320, OM-ID-0420 | 2024 | 16 |
| Tourniquet, Pneumatic | Class 1 | Ortus, Disposable Pressure Bandage, OM-TB02, OM-TB03 | 2024 | 21 |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2014 |
|---|---|
| Main products | interventional cardiology devices, radiology devices, hemostasis kits |
| Certifications | ISO13485:2016, CE |
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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