Manufacturer
Fisher & Paykel Healthcare
New ZealandLegal entities : Fisher & Paykel Healthcare Limited
Markets : Austria · Denmark · Finland · France · Germany · Ireland · Italy · Malta · Netherlands · Northern Ireland · Poland · Portugal · Romania · Spain · Sweden · United States
Approvals : EU – class IIa, IIb · United States (FDA) – 510(k) : 87 · class II · latest in 2026 · see on the FDA website
Public contracts won : France 65 · Spain 13 · Sweden 12 · Poland 5 · Denmark 3 · Italy 3 · Finland 1 · Ireland 1
EU representative : FISHER & PAYKEL HEALTHCARE SAS (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 |
|---|---|---|---|---|
| Adult and paediatric/neonatal pulmonary ventilators | Z1203010504 |
3 others |
IIa, IIb MDR, 93/42 | EUDAMED record Report an error |
| Various instruments for anaesthesia and pulmonary ventilation support - other | Z1203019099 |
|
IIa MDR, 93/42 | EUDAMED record Report an error |
| Various instruments for anaesthesia and pulmonary ventilation support - software accessories | Z1203019082 |
|
IIb MDR | EUDAMED record Report an error |
| Various instruments for general and multidisciplinary surgery - consumables | Z12019085 | IIa MDR | EUDAMED record Report an error | |
| Various instruments for general and multidisciplinary surgery - hardware accessories | Z12019080 | 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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