Manufacturer
Spacelabs Healthcare
United Kingdom (ex Northern Ireland)Legal entities : Spacelabs Healthcare Ltd.
Markets : France · Germany · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 20 · class I, II · latest in 2022 · see on the FDA website
Public contracts won : France 18
EU representative : MediMark Europe Sarl. (France)
- 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 |
|---|---|---|---|---|
| Blood pressure holter recorders | Z12050404 | I, IIa MDR | EUDAMED record Report an error | |
| Holter system instruments for cardiovascular parameters - consumables | Z12050485 | I MDR | EUDAMED record Report an error | |
| ECG holter recorders | Z12050403 |
|
IIa MDR | EUDAMED record Report an error |
| Cardiovascular holter analysers | Z12050401 | IIa MDR | EUDAMED record Report an error | |
| Holter system instruments for cardiovascular parameters - other | Z12050499 | I MDR | EUDAMED record Report an error | |
| Holter system instruments for cardiovascular parameters - software accessories | Z12050482 | IIa MDR | EUDAMED record Report an error | |
| Non-invasive blood pressure gauges - other | Z1203020599 | I MDR | EUDAMED record Report an error |
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