Manufacturer
Shenzhen Root Innovation Technology
ChinaLegal entities : Shenzhen Root Innovation Technology Co., Ltd.
Markets : France · Germany · Malta · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 13 · class I, II · latest in 2026 · see on the FDA website
EU representative : MedPath GmbH (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 |
|---|---|---|---|---|
| Medical support equipment - other | V0899 | I MDR | EUDAMED record Report an error | |
| Breast pumps | Z12080303 | IIa MDR | EUDAMED record Report an error | |
| Gynaecology and maternal-infants instruments - other | Z120899 | I MDR | EUDAMED record Report an error |
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