Data / Medical devices / China / Guangdong Xinyu Electronic And Technology Co., Ltd
Guangdong Xinyu Electronic And Technology Co., Ltd: FDA-registered device maker in ZHONGSHAN Guangdong, China, 2 510(k) clearances
Guangdong Xinyu Electronic And Technology Co., Ltd is registered with the FDA (registration 3013510081) in ZHONGSHAN Guangdong, China. It lists 2 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 11, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013510081
- Address
- Number 42, Cuicheng Road, Cuiheng New District, ZHONGSHAN Guangdong, China, 528400
- Owner or operator
- GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD (10054235)
- Roles
- Contract manufacturer, Manufacturer
- First device listed
- January 17, 2019
- Registered through
- 2026
- Brand names listed
- Arm Blood Pressure Monitor, XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09, Wrist Blood Pressure Monitor, XY-W01A, XY-W01B, XY-6010 XY-6012 XY-6013 XY-6015A XY-6015B XY-6016 XY-6026 XY-6028 XY-6039 XY-6051 XY-6052 XY-6055 XY-6058, XY-6061 XY-6063 XY-6065 XY-6066 XY-6068 XY-6069 XY-6069N XY-6070 XY-6071 XY-6073 XY-6075 XY-6076 XY-6078, XY-6079 XY-6080 XY-6081 XY-6082 XY-6085 XY-6086 XY-6088 XY-6089 XY-6090 XY-6091 XY-6092 XY-6093 XY-6095, XY-6168 XY-6169,XY-6169-BO XY-6061-BO,XY-6025 XY-6027 XY-6029 XY-6030 XY-6031 XY-6032 XY-6033 XY-6035, XY-6711 XY-6010 XY-6705 XY-6701 XY-6702 XY-6706 BF180, BF179, ES-32MD, XY-M01B, XY-6110, XY-6112, XY-6103, XY-6101, XY-6008, XY-6009, XY-6107, XY-6109
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | PUH | 2 | Contract manufacturer, 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 |
|---|---|---|---|---|---|---|
| February 11, 2025 | K241634 | Wrist Blood Pressure Monitor (XY-W01A, XY-W01B) | DXN | Substantially Equivalent | Guangdong Xinyu Electronic and Technology Co., Ltd. | accessdata.fda.gov |
| February 3, 2025 | K241590 | Arm Blood Pressure Monitor (XY-B01, XY-B02, XY-B03, XY-B05, XY-B07, XY-B08, XY-B09) | DXN | Substantially Equivalent | Guangdong Xinyu Electronic and Technology Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Analyzer, Body Composition, Exempt
Updated February 11, 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.