Manufacturer
Surgnova
ChinaLegal entities : Surgnova Healthcare Technologies (Zhejiang) Co., Ltd.
Markets : Croatia · Cyprus · France · Germany · Greece · Italy · Slovenia · Spain · United States
Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 7 · class II · latest in 2024 · see on the FDA website
EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany)
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a category to see competitors, a model to open its EUDAMED record.
| Category | EMDN code | Registered models | Class | Contact |
|---|---|---|---|---|
| Ultrasonic scalpel | Z12010801 | IIb MDR | EUDAMED record Report an error | |
| Instruments for ultrasonic surgery - hardware accessories | Z12010880 |
|
I, IIa MDR | EUDAMED record Report an error |
| Electroporation devices | W02050105 | IIb MDR | EUDAMED record Report an error | |
| Gas inflators | Z12029008 |
|
IIa MDR | EUDAMED record Report an error |
| Microwave therapy equipment | Z120608 | IIb MDR | EUDAMED record Report an error |
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