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Evo Autoimmune SPA
EUDAMEDClass A (EU MDR)
Ref 3AX4020 ANAModel Evo Autoimmune SPA
by Abd Srl
Identity
- Trade Name
- Evo Autoimmune SPA EUDAMED
- Device Name
- Autoimmunity SPA ANA Screen - Autoimmunità SPA ANA Screen EUDAMED
- Model / Reference
- Evo Autoimmune SPA EUDAMED3AX4020 ANA EUDAMED
Identifiers
- Primary DI / UDI-DI
- 48058945154692 EUDAMED
- Basic UDI-DI
- 8058945153AX4020ANAWC EUDAMED
- Direct Marketing DI
- 48058945154692 EUDAMED
- EMDN Code
- W0102100101 ANA SCREENING EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Italy EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMED
Animal Tissues
Yes
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
No
EUDAMED
New Device
No
EUDAMED
Evo Autoimmune SPA by Abd Srl — Class A — CE/MDR — 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 | 8058945153AX4020ANAWC | Class A | Active |
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Manufacturer
- Manufacturer
- Abd Srl
- EUDAMED SRN
- IT-MF-000029729
Sources (1)
- EUDAMED 3bdf0d0d-2fff-4d89-8cb3-19d5b739a9f2 61 fields · synced Oct 7, 2026