Data / Medical devices / China / Shenzhen Harveymed Technology Co., Ltd.
Shenzhen Harveymed Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Harveymed Technology Co., Ltd. is registered with the FDA (registration 3033814505) in Shenzhen Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033814505
- Address
- B203 Weike science and technology building, No. 20, Gaoxin West Road, Dongzhou community Guangming Street, Guangming District, Shenzhen Guangdong, China, 518083
- Owner or operator
- Shenzhen HarveyMed Technology Co., Ltd. (10091599)
- Roles
- Manufacturer
- First device listed
- October 17, 2024
- Registered through
- 2026
- Brand names listed
- HarveyMed, V series portable oxygen concentrator, Model: V5, V5C, V6, V6C, HarveyMed; Cannula, Nasal Oxygen; HVNC01, Portable Oxygen Concentrator, Model: V5, V5C, V6, V6C, Protekt Deluxe POC, Model: PMPOC
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Cannula, Nasal, Oxygen | CAT | 1 | Manufacturer | accessdata.fda.gov |
| Generator, Oxygen, Portable | CAW | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2025 | K252268 | V series portable oxygen concentrator (V5, V5C, V6, V6C) | CAW | Substantially Equivalent | Shenzhen Harveymed Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated December 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.