Identity
- Device Name
- MAX 45k EUDAMED
- Model / Reference
- 16-0000-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120122921609 EUDAMED
- Basic UDI-DI
- 91201229216K3 EUDAMED
- Direct Marketing DI
- 09120122921609 EUDAMED
- EMDN Code
- W0201020101 AUTOMATED IMMUNOCHEMISTRY ANALYSERS - LOW ROUTINE (Throughput <= 100 test/h) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Austria EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Microbial Substances
No
EUDAMED
Reagent
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
MAX 45k by MacroArray Diagnostics — Class A — 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 | 91201229216K3 | Class A | Active |
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Manufacturer
- Manufacturer
- MacroArray Diagnostics
- EUDAMED SRN
- AT-MF-000030541
Sources (1)
- EUDAMED 671631be-991f-400b-b2d5-b4e7bbc4f7de 61 fields · synced Oct 7, 2026