Identity
- Device Name
- ALEX Air EUDAMED
- Model / Reference
- 06-5001-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120122920657 EUDAMED
- Basic UDI-DI
- 91201229206JY EUDAMED
- Direct Marketing DI
- 09120122920657 EUDAMED
- EMDN Code
- W01020205 IMMUNOGLOBULIN E - SCREEN EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
Yes
EUDAMED
Microbial Substances
Yes
EUDAMED
Reagent
Yes
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
No
EUDAMED
New Device
No
EUDAMED
ALEX Air by MacroArray Diagnostics — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 91201229206JY | Class C | Active |
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Manufacturer
- Manufacturer
- MacroArray Diagnostics
- EUDAMED SRN
- AT-MF-000030541
Sources (1)
- EUDAMED 6cd3f02f-3e16-46db-ae3e-2b8fd6a390f9 61 fields · synced Oct 6, 2026