Xian Friendship Medical Electronics Co., Ltd.
Registered establishment in Xi'An, Shaanxi, China. 10 device types, 3 clearances.
Xian Friendship Medical Electronics Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Electrode, Needle, Stimulator, Nerve and 8 other device types. Its earliest product listing with the FDA dates from 2007.
10device types registered with the FDA
3510(k) clearances
Registration
| Status | Registered |
|---|---|
| Registration expires | 2026 |
| Registration number | 3003851073 |
| FEI number | 3003851073 |
| Establishment type | Contract manufacturer, Manufacturer |
Location
| City | Xi’An |
|---|---|
| Province | Shaanxi |
| Address | No.9 Gao Xin 1st Road, High-Tech Development Zone |
| Postal code | 710075 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Electrode, Cutaneous | Class 2 | Friendship Medical, Sunspots, Medtronic | 2007 | 47 |
| Electrode, Needle | Class 2 | Medtronic, Friendship Medical, Sunspots | 2007 | 4 |
| Electromyograph, Diagnostic | Class 2 | Medtronic | 2011 | 2 |
| Full-Montage Standard Electroencephalograph | Class 2 | Medtronic | 2011 | 3 |
| Stimulator, Auditory, Evoked Response | Class 2 | Medtronic | 2011 | 4 |
| Stimulator, Electrical, Evoked Response | Class 2 | Medtronic | 2011 | 3 |
| Stimulator, Nerve | Class 2 | Medtronic, Friendship Medical, Cadwell Industries Inc. | 2011 | 8 |
| Stimulator, Photic, Evoked Response | Class 2 | Medtronic | 2011 | 1 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | Medtronic | 2011 | 22 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Medtronic | 2011 | 44 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K112426 | 2012-04-02 | ETN | Traditional | This company |
| K110289 | 2011-08-30 | GXY | Traditional | This company |
| K072276 | 2008-05-16 | GXZ | Traditional | This company |
Nearby Manufacturers
| Manufacturer | Device types |
|---|---|
| Xian Tianlong Science AND Technology Co., Ltd. | 8 |
| Xi’an Furuize Biotechnology Co., Ltd. | 8 |
| Shaanxi Ansen Medical Technology Development Co., Ltd. | 7 |
| Kontour (Xi’an) Medical Technology Co., Ltd. | 4 |
| Xi’an Haiye Medical Equipment Co,.ltd. | 3 |
| Xi’an Henghui Technology, Ltd | 1 |
| Xi’an Centeringone International Trading & Consultants Ltd. | 1 |
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.
The manufacturer named here can complete this record.