Manufacturer
Sophway
ChinaLegal entities : Shenzhen Sophway Technology Co.,Ltd.
Markets : Austria · Greece · Poland · Türkiye · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 2 · class II · latest in 2025 · see on the FDA website
EU representative : Umedwings Netherlands B.V. (Netherlands)
- 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 |
|---|---|---|---|---|
| Gas inflators | Z12029008 | IIa MDR | EUDAMED record Report an error | |
| Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images | Z12020401 | I MDR | EUDAMED record Report an error | |
| Light sources for endoscopy and minimally invasive surgery | Z12020402 | I MDR | EUDAMED record Report an error |
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