Data / Medical devices / Hong Kong / Globalcare Medical Technology HK, Ltd.
Globalcare Medical Technology HK, Ltd.: FDA-registered device maker in Hong Kong, Hong Kong, 6 510(k) clearances
Globalcare Medical Technology HK, Ltd. is registered with the FDA (registration 3010205626) in Hong Kong, Hong Kong. It lists 5 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 22, 2022. Registered through 2027. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3010205626
- Address
- Room25 4/F, Tung Hip Commercial Building 244 Des Voeux Rd Central, Sheung Wan, Hong Kong, Hong Kong, Hong Kong, NA
- Owner or operator
- Globalcare Medical Technology HK, Ltd. (10046453)
- Roles
- Exporter to the US
- First device listed
- March 24, 2014
- Registered through
- 2027
- Brand names listed
- NEB200
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Exporter to the US | accessdata.fda.gov |
| Nebulizer (Direct Patient Interface) | CAF | 2 | Exporter to the US | accessdata.fda.gov |
| Pump, Breast, Powered | HGX | 2 | Exporter to the US | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 2 | Exporter to the US | 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 |
|---|---|---|---|---|---|---|
| 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 Nebulizer (Direct Patient Interface)
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Mask, Oxygen
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Pump, Breast, Powered
Updated November 22, 2022. 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.