Data / Medical devices / China / Hygea Medical Technology Co., Ltd.
Hygea Medical Technology Co., Ltd.: FDA-registered device maker in Beijing, China, 2 510(k) clearances
Hygea Medical Technology Co., Ltd. is registered with the FDA (registration 3039443404) in Beijing, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated January 29, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3039443404
- Address
- Floors 1 to 4 of Building 31, Floors 1 to 3 of Building 32,No. 69 Qingfeng West Road, Daxing District, Beijing, China, 102600
- Owner or operator
- Hygea Medical Technology Co., Ltd. (10093771)
- Roles
- Manufacturer
- First device listed
- July 11, 2025
- Registered through
- 2026
- Brand names listed
- Co-Ablation System, Microwave Ablation Device, Sterile Co-Ablation Probe, Sterile Microwave Ablation Probe
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| System, Ablation, Microwave And Accessories | NEY | 2 | Manufacturer | accessdata.fda.gov |
| Unit, Cryosurgical, Accessories | GEH | 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 |
|---|---|---|---|---|---|---|
| January 29, 2025 | K243042 | Co-Ablation System with Sterile Co-Ablation Probe | GEH | Substantially Equivalent | Hygea Medical Technology Co., Ltd. | accessdata.fda.gov |
| January 31, 2024 | K233140 | Microwave Ablation Device (Exceed S10U); Sterile Microwave Ablation Probe (Exact) | NEY | Substantially Equivalent | Hygea Medical Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Unit, Cryosurgical, Accessories
- All makers of System, Ablation, Microwave And Accessories
Updated January 29, 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.