Manufacturer
Mediana
South KoreaLegal entities : MEDIANA CO., LTD
Markets : Belgium · Bulgaria · Croatia · Cyprus · Czechia · Estonia · Finland · France · Germany · Greece · Hungary · Ireland · Italy · Latvia · Lithuania · Netherlands · Norway · Poland · Portugal · Romania and 4 more countries
Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 10 · class I, II · latest in 2020 · see on the FDA website
EU representative : Obelis s.a. (Belgium)
- 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 |
|---|---|---|---|---|
| Multi-parameter patient bedside monitors | Z1203020201 | IIb 93/42 | EUDAMED record Report an error | |
| Body impedance analysers | Z12099001 | IIa 93/42 | EUDAMED record Report an error | |
| Automatic defibrillators | Z12030503 |
|
IIb 93/42 | EUDAMED record Report an error |
| Manual defibrillators | Z12030502 | IIb 93/42 | EUDAMED record Report an error | |
| Semi-automatic defibrillators | Z12030501 |
|
IIb 93/42 | EUDAMED record Report an error |
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