Data / Medical devices / China / ShenZhen GoodlyMed Technology Co.,Ltd.
ShenZhen GoodlyMed Technology Co.,Ltd.: FDA-registered device maker in shenzhen Guangdong, China, 1 510(k) clearance
ShenZhen GoodlyMed Technology Co.,Ltd. is registered with the FDA (registration 3032171377) in shenzhen Guangdong, China. It lists 3 device types. The FDA files 1 510(k) clearance under its listings, the newest dated July 3, 2024. Registered through 2026. 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
- 3032171377
- Address
- 701, Building C, Area C, Datianyang Industrial Zone, Shiwei Community, Matian Street, Guangming District, shenzhen Guangdong, China, 518107
- Owner or operator
- ShenZhen GoodlyMed Technology Co.,Ltd. (10091134)
- Roles
- Manufacturer
- First device listed
- July 10, 2024
- Registered through
- 2026
- Brand names listed
- A02-SE4, A02-SEB, A02-BE, A02-SE, A02-E, A01-SLB, A01-BS, A01-BL, A01-SL, A01,A02-SE5,A02-E4,A02-B,A02-N,A11,A12, A40-L,A40-L1,A40-1,A40-2,A40-BE,A40-E1,A40-E2,A40-E, Andesfit ADF-B62,Andesfit ADF-B481, Digital Thermometer, Massager UD-206,UD-207,UD-208,UD-300,UD-301,UD-302,UD-500,UD-100,UD-101,UD-102,UD-103,UD-701,UD-702,UD-700, Upper Arm Electronic Blood Pressure Monitor
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Clinical Electronic Thermometer | SDV | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 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 |
|---|---|---|---|---|---|---|
| July 3, 2024 | K241129 | Upper Arm Electronic Blood Pressure Monitor | DXN | Substantially Equivalent | Shenzhen Goodlymed Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Massager, Therapeutic, Electric
- All makers of Clinical Electronic Thermometer
Updated July 3, 2024. 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.