Data / Medical devices / Hong Kong / Ehealth Science And Technology(hong Kong) Co., Ltd
Ehealth Science And Technology(hong Kong) Co., Ltd: FDA-registered device maker in Hongkong, Hong Kong, 2 510(k) clearances
Ehealth Science And Technology(hong Kong) Co., Ltd is registered with the FDA (registration 3024379416) in Hongkong, Hong Kong. It lists 3 device types. The FDA files 2 510(k) clearances under its listings, the newest dated March 20, 2020. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3024379416
- Address
- Flat/Rm 04-05 16/F The Broadway No 54-62 Lockhart Road Wanchai, Hongkong, Hong Kong, 000000
- Owner or operator
- EHEALTH SCIENCE AND TECHNOLOGY(HONG KONG) CO., LTD (10086256)
- Roles
- Exporter to the US
- First device listed
- October 25, 2022
- Registered through
- 2026
- Brand names listed
- Blood Glucose Meter, DX-206,DX-207,DX-208,DX-300.DX-301,DX-302 ,MC1, EYE MASSAGER, Fingertip Pulse Oximeter, YK-83C, G-427B, MG1, MB1
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Massager, Therapeutic, Electric | ISA | 1 | Exporter to the US | accessdata.fda.gov |
| Oximeter | DQA | 2 | Exporter to the US | accessdata.fda.gov |
| System, Test, Blood Glucose, Over The Counter | NBW | 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 |
|---|---|---|---|---|---|---|
| March 20, 2020 | K191657 | Bioland Blood Glucose Monitoring System | NBW | Substantially Equivalent | Bioland Technology, Ltd. | accessdata.fda.gov |
| May 8, 2017 | K161938 | Fingertip Pulse Oximeter | DQA | Substantially Equivalent | Xuzhou Yongkang Electronic Science Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Massager, Therapeutic, Electric
- All makers of Oximeter
- All makers of System, Test, Blood Glucose, Over The Counter
Updated March 20, 2020. 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.