Data / Medical devices / China / Globalcare Medical Technology Co., Ltd
Globalcare Medical Technology Co., Ltd: FDA-registered device maker in Zhongshan City Guangdong, China, 8 510(k) clearances
Globalcare Medical Technology Co., Ltd is registered with the FDA (registration 3010880718) in Zhongshan City Guangdong, China. It lists 8 device types. The FDA files 8 510(k) clearances under its listings, the newest dated March 4, 2026. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 3010880718
- Address
- 7th Building, 39 Middle Industrial Main Road, European Industrial Zone Xiaolan Town, Zhongshan City Guangdong, China, 528415
- Owner or operator
- Globalcare Medical Technology Co., Ltd (10046812)
- Roles
- Manufacturer, Specification developer
- First device listed
- May 16, 2014
- Registered through
- 2027
- Brand names listed
- NEB 200, NEB200
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Blood Pressure Cuff | DXQ | 2 | Specification developer | accessdata.fda.gov |
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Manufacturer | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Manufacturer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Specification developer | accessdata.fda.gov |
| Stimulator, Nerve, Transcutaneous, Over-The-Counter | NUH | 2 | Specification developer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| March 4, 2026 | K253896 | TENS/EMS device (GUSE01) | NUH | Substantially Equivalent | Globalcare Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 8, 2025 | K250136 | Globalcare Blood Pressure Monitor (GUS610) | DXN | Substantially Equivalent | Globalcare Medical Technology Co., Ltd. | accessdata.fda.gov |
| November 22, 2022 | K222160 | GUS610 Blood pressure monitor | DXN | Substantially Equivalent | Globalcare Medical Technology Co., Ltd. | accessdata.fda.gov |
| May 1, 2020 | K192633 | GUS831 Compressor Nebulizer | CAF | Substantially Equivalent | Globalcare Medical Technology Co., Ltd. | accessdata.fda.gov |
| April 21, 2020 | K192609 | Globalcare Blood Pressure Monitor | DXN | Substantially Equivalent | Globalcare Medical Technology Co., Ltd. | accessdata.fda.gov |
| June 18, 2018 | K172842 | GCE704 Breast Pump | HGX | Substantially Equivalent | Globalcare | accessdata.fda.gov |
| October 21, 2002 | K021443 | 56 SERIES JET NEBULIZER | CAF | Substantially Equivalent | Project Marketing | accessdata.fda.gov |
| June 12, 1998 | K980074 | 56 SERIES AEROSOL GENERATOR | CAF | Substantially Equivalent | Project Marketing | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Nebulizer (Direct Patient Interface)
- All makers of Blood Pressure Cuff
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Stimulator, Nerve, Transcutaneous, Over-The-Counter
- All makers of Mask, Oxygen
Updated March 4, 2026. 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.