Sunny Medical Device (Shenzhen) Co., Ltd.
Manufacturer and brand owner in Shenzhen, Guangdong, China. 11 device types, 12 products catalogued, 6 clearances.
Sunny Medical Device (Shenzhen) Co., Ltd. is a contract manufacturer holding a current FDA establishment registration. The registration covers Trocar, Clamp, Vascular and 9 other device types. 12 of its products are catalogued under its own name. Its earliest product listing with the FDA dates from 2013.
Registration
| Registered name | SUNNY MEDICAL DEVICE (SHENZHEN) CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3007361214 |
| FEI number | 3007361214 |
| DUNS | 529639795 |
| Establishment type | Contract manufacturer, Manufacturer |
Chinese Registration
| Chinese legal name | 深圳市昕力医疗设备开发有限公司 |
|---|---|
| Unified social credit code | 914403007488755871 |
| Source | export sales certificate, Guangdong medical products administration |
Location
| City | Shenzhen |
|---|---|
| Province | Guangdong |
| Address | 1/F, Zhongtianxin Building B |
| Postal code | 518172 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Accessory, Surgical Apparel | Class 1 | SunmedTM Protective face shield | 2020 | 439 |
| Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass | Class 2 | SunmedTM Manifold and Stopcocks | 2016 | 13 |
| Applier, Surgical, Clip | Class 1 | 2020 | 9 | |
| Catheter, Intravascular, Diagnostic | Class 2 | SunmedTM High Pressure Line | 2015 | 11 |
| Clamp, Vascular | Class 2 | 2020 | 10 | |
| Injector And Syringe, Angiographic | Class 2 | SunmedTM Control Syringes, AirTightTM Control Syringes | 2016 | 15 |
| Syringe, Balloon Inflation | Class 2 | SunmedTM Inflation Device | 2015 | 6 |
| Syringe, Balloon Inflation, Exempt | Class 2 | SunmedTM Inflation Device | 2019 | 16 |
| Trocar | Class 2 | 2019 | 9 | |
| Wire, Guide, Catheter | Class 2 | Sunmed | 2013 | 10 |
| Wire, Guide, Catheter, Exempt | Class 2 | SunmedTM guidewire torque device | 2020 | 5 |
Own-Brand Listings
| Product | Code | Catalogue numbers |
|---|---|---|
| Sunmed Guide Wires | DQX | 9 |
| Sunmed Inflation Device | PTM | 3 |
| Sunmed Haemostatic Valves | DTL | 1 |
| Sunmed guidewire torque device | PTL | 1 |
| Sunmed Inflation Device | MAV | 1 |
| Sunmed Inflation devices | MAV | 1 |
| Sunmed Manifold and Stopcocks | DTL | 1 |
| Sunmed disposable angio-closure pads | DXC | 1 |
| Sunmed disposable needles | DRC | 1 |
| AirTight Control Syringes | DXT | 1 |
| Sunmed High Pressure Line | DQO | 1 |
| Sunmed Protective face shield | LYU | 1 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K191827 | 2020-03-16 | DXC | Traditional | This company |
| K160190 | 2016-11-10 | DXT | Traditional | This company |
| K153685 | 2016-10-13 | DQX | Traditional | This company |
| K140356 | 2015-03-20 | DQO | Traditional | This company |
| K133795 | 2014-12-12 | MAV | Traditional | This company |
| K120119 | 2012-05-11 | DQX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2003 |
|---|---|
| Main products | Balloon dilatation devices, Guide wires, Y connectors, Angiographic needles, Cardiology intervention products |
| Certifications | CE, ISO13485, FDA 510(k) |
| Export markets | International markets including Europe |
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.