Data / Medical devices / Hong Kong / Homedica Limited
Homedica Limited: FDA-registered device maker in Kl, Hong Kong, 2 510(k) clearances
Homedica Limited is registered with the FDA (registration 3044854644) in Kl, Hong Kong. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated February 14, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3044854644
- Address
- Unit 3,6/F Kam Hon Industrial Building 8 Wang Kwun Road Kowloon Bay, Kl, Hong Kong, 999073
- Owner or operator
- HOMEDICA LIMITED (10095486)
- Roles
- Exporter to the US
- First device listed
- March 19, 2026
- Registered through
- 2026
- Brand names listed
- Goodbaby, Thermometer, model FC-IR100, Goodbaby, Thermometer, model FC-IR2000, Goodbaby, Thermometer, model FC-IR202
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | 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 |
|---|---|---|---|---|---|---|
| February 14, 2025 | K243136 | Non-contact Forehead Infrared Thermometer (FC-IR2000, FC-IR205, FC-IR202, FC-IR206, FC-IR207, FC-IR209) | FLL | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
| January 2, 2019 | K181215 | Infrared Thermometer | FLL | Substantially Equivalent | Shenzhen Finicare Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated February 14, 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.