Manufacturer
Rooti Labs
TaiwanLegal entities : Rooti Labs Limited.
First countries of placing on the market declared in EUDAMED : Belgium
EU representative : Wellkang Ltd (Northern Ireland)
- 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 |
|---|---|---|---|---|
| Cardiac telemetry instruments - hardware accessories | Z12050880 |
|
I MDR | EUDAMED record Report an error |
| Cardiac telemetry instruments - medical device software | Z12050892 | IIa MDR | EUDAMED record Report an error | |
| ECG holter recorders | Z12050403 |
|
IIa MDR | EUDAMED record Report an error |
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
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