Guangdong Xinyu Electronic AND Technology Co., Ltd.
Manufacturer and brand owner in Zhongshan, Guangdong, China. 2 device types, 1 product catalogued, 2 clearances.
Guangdong Xinyu Electronic AND Technology Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Analyzer, Body Composition, Exempt, System, Measurement, Blood-Pressure, Non-Invasive. 1 of its products is catalogued under its own name. Its earliest product listing with the FDA dates from 2019.
2device types registered with the FDA
1product
2510(k) clearances
Registration
| Registered name | GUANGDONG XINYU ELECTRONIC AND TECHNOLOGY CO., LTD |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3013510081 |
| FEI number | 3013510081 |
| DUNS | 543039448 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Zhongshan |
|---|---|
| Province | Guangdong |
| Address | NUMBER 42, CUICHENG ROAD, CUIHENG NEW DISTRICT |
| Postal code | 528400 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Analyzer, Body Composition, Exempt | Class 2 | XY-6711 XY-6010 XY-6705 XY-6701 XY-6702 XY-6706 BF180, BF179, ES-32MD, 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-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-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-M01B, XY-6110, XY-6112, XY-6103, XY-6101, XY-6008, XY-6009, XY-6107, XY-6109 | 2019 | 36 |
| System, Measurement, Blood-Pressure, Non-Invasive | Class 2 | 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 | 2025 | 98 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K241634 | 2025-02-11 | DXN | Traditional | This company |
| K241590 | 2025-02-03 | DXN | Traditional | This company |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
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