Shenzhen Wisonic Medical Technology Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 4 device types, 16 products catalogued, 7 clearances.
Shenzhen Wisonic Medical Technology Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Biopsy Needle Guide Kit, Transducer, Ultrasonic, Diagnostic and 2 other device types. 16 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2018.
Registration
| Registered name | SHENZHEN WISONIC MEDICAL TECHNOLOGY CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3014302721 |
| FEI number | 3014302721 |
| DUNS | 543063066 |
| Establishment type | Manufacturer, Exporter |
Chinese Registration
| Chinese legal name | 深圳华声医疗技术股份有限公司 |
|---|---|
| Unified social credit code | 914403000627168059 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | Building 9, Baiwang Creative Factory, No. 1051, Songbai Road, Xili Street, Nanshan District, 518055 Shenzhen, |
| Postal code | 518055 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Biopsy Needle Guide Kit | Class 2 | Biopsy Needle Guide Kit; Disposable Needle Guides; Reusable Needle Guides | 2020 | 4 |
| System, Imaging, Pulsed Doppler, Ultrasonic | Class 2 | Labat series Diagnostic Ultrasound System | 2018 | 22 |
| System, Imaging, Pulsed Echo, Ultrasonic | Class 2 | Labat series Diagnostic Ultrasound System | 2018 | 37 |
| Transducer, Ultrasonic, Diagnostic | Class 2 | Labat series Diagnostic Ultrasound System | 2018 | 44 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Wisonic | IYN | 22 |
| Wisonic | ITX | 21 |
| Diagnostic Ultrasound System | IYN | 16 |
| Wisonic | IYO | 7 |
| Ultrasonic Transducer | ITX | 6 |
| Rechargeable Li-ion Battery Pack | IYN | 2 |
| Magnetic cup | IYN | 2 |
| Gel warmer | IYN | 1 |
| Probe extender | IYN | 1 |
| TEE Articulated Arm | IYN | 1 |
| ECG module | IYN | 1 |
| Foot Switch | IYN | 1 |
| Laser Marker | IYN | 1 |
| Transducer Extender | IYN | 1 |
| Barcode Reader | IYN | 1 |
| Mobile Trolley | IYN | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K230066 | 2023-09-15 | IYN | Traditional | This company |
| K211886 | 2021-12-02 | IYN | Traditional | This company |
| K210154 | 2021-07-30 | IYN | Traditional | This company |
| K191347 | 2020-02-07 | IYN | Traditional | This company |
| K182715 | 2018-11-20 | IYN | Traditional | This company |
| K180461 | 2018-05-09 | IYN | Traditional | This company |
| K163712 | 2018-01-02 | IYN | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2012 |
|---|---|
| Main products | Maternity screening ultrasound, Anesthesia/pain ultrasound, Bedside ultrasound, Critical care ultrasound, Rehabilitation ultrasound |
| Certifications | National High-Tech Enterprise, ISO13485, CFDA |
| Export markets | USA, Germany, Hong Kong |
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.
The manufacturer named here can complete this record.