Identity
- Trade Name
- NIKI2002-SEM EUDAMED
- Device Name
- SISTEMA DI EVACUAZIONE MOBILE A DOPPIA MASCHERA NIKI2002 EUDAMED
- Model / Reference
- NIKI2002 EUDAMED010093 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08055304120000 EUDAMED
- Basic UDI-DI
- 805530412NIKIA5 EUDAMED
- Direct Marketing DI
- 08055304120000 EUDAMED
- EMDN Code
- R9099 RESPIRATORY AND ANAESTHESIA DEVICES - OTHER EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Implantable
No
EUDAMED
Reusable
No
EUDAMED
Contains Latex
No
EUDAMED
Reprocessed
No
EUDAMED
CMR Substance
No
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
Yes
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Category: Pulmonary function analysis system, adult
Niki2002-Sem by Airnova Srl — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/MDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/MDR | 805530412NIKIA5 | Class I | Active |
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Manufacturer
- Manufacturer
- Airnova Srl
- EUDAMED SRN
- IT-MF-000011251
Sources (1)
- EUDAMED adcc0702-b7c0-4327-9306-4e6ea9997b47 61 fields · synced Jul 16, 2026