Identity
- Trade Name
- ClearAir2 EUDAMED
- Device Name
- Smoke Evacuation Unit EUDAMED
- Model / Reference
- PMS900SE EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15060418450912 EUDAMED
- Basic UDI-DI
- 506041845PMS900SEKF EUDAMED
- EMDN Code
- Z12019004 SURGICAL SMOKE EVACUATION SYSTEMS EUDAMED
Classification
- Device Class
- Class I EUDAMED
- Market of Registration
- Austria 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
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
ClearAir2 by Prima Medical Ltd — Class I — MDR — listed in EUDAMED — regulatory data on deviCERTS
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 | 506041845PMS900SEKF | Class I | Active |
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Manufacturer
- Manufacturer
- Prima Medical Ltd
- EUDAMED SRN
- UK-MF-000045180
- Authorised Representative
- Obelis s.a. BE-AR-000000106
Sources (1)
- EUDAMED 11110f61-cc52-415a-a091-a473e4e14390 61 fields · synced Sep 18, 2026