Shenzhen Harveymed Technology Co., Ltd.
Registered establishment in Shenzhen, Guangdong, China. 2 device types, 1 clearance.
Shenzhen Harveymed Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Cannula, Nasal, Oxygen, Generator, Oxygen, Portable. Its earliest product listing with the FDA dates from 2024.
2device types registered with the FDA
1510(k) clearance
Registration
| Registered name | SHENZHEN HARVEYMED TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3033814505 |
| FEI number | 3033814505 |
| Establishment type | Manufacturer |
Chinese Registration
| Chinese legal name | 深圳哈维生物医疗科技有限公司 |
|---|---|
| Source | Qichacha company register |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | B203 Weike science and technology building, No. 20, Gaoxin West Road, Dongzhou community |
| Postal code | 518083 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | Class 1 | HarveyMed; Cannula, Nasal Oxygen; HVNC01 | 2024 | 97 |
| Generator, Oxygen, Portable | Class 2 | Portable Oxygen Concentrator, Model: V5, V5C, V6, V6C, Protekt Deluxe POC, Model: PMPOC, HarveyMed, V series portable oxygen concentrator, Model: V5, V5C, V6, V6C | 2025 | 22 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252268 | 2025-12-16 | CAW | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2019 |
|---|---|
| Main products | Portable oxygen concentrators, Ventilators, Respiratory support devices, ICU equipment, Emergency care equipment |
| Certifications | FDA 510(k) certification |
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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