Manufacturer
Laerdal
NorwayLegal entities : Laerdal Medical AS
Markets : Belgium · Finland · France · Germany · Netherlands · Norway · Poland · Spain · Sweden · UK · United States
Approvals : EU – class I, IIa · United States (FDA) – 510(k) : 20 · class I, II, III · latest in 2025 · see on the FDA website
Public contracts won : France 32 · Spain 5 · Germany 4 · Norway 3 · Netherlands 2 · Belgium 1 · Finland 1 · Sweden 1 · UK 1
- 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 |
|---|---|---|---|---|
| Foetal heartbeat detectors | Z12080103 | IIa 93/42 | EUDAMED record Report an error | |
| Biofeedback instruments - consumables | Z12062485 | I 93/42 | EUDAMED record Report an error | |
| Biofeedback instruments - hardware accessories | Z12062480 | I 93/42 | EUDAMED record Report an error | |
| Cervical spine orthoses | Y060312 |
|
I MDR | EUDAMED record Report an error |
| Foetal monitors | Z12080101 |
|
IIa 93/42 | 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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