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Evo Autoimmune Standard, anti-b2-GPI IgG
EUDAMEDClass A (EU MDR)
Ref 3AU2000/12GModel Evo Autoimmune Standard, anti-b2-GPI IgG
by Abd Srl
Identity
- Trade Name
- Evo Autoimmune Standard, anti-b2-GPI IgG EUDAMED
- Device Name
- Standard anti-b2-GPI IgG - Standard anti-b2-GPI IgG EUDAMED
- Model / Reference
- Evo Autoimmune Standard, anti-b2-GPI IgG EUDAMED3AU2000/12G EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08058945155639 EUDAMED
- Basic UDI-DI
- 8058945153AU2000/12GZ8 EUDAMED
- Direct Marketing DI
- 08058945155639 EUDAMED
- EMDN Code
- W0102152211 STANDARDS AND CALIBRATORS FOR AUTOIMMUNITY 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
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
Evo Autoimmune Standard, anti-b2-GPI IgG by Abd Srl — 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 | 8058945153AU2000/12GZ8 | Class A | Active |
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Manufacturer
- Manufacturer
- Abd Srl
- EUDAMED SRN
- IT-MF-000029729
Sources (1)
- EUDAMED 69ecf9bd-c223-481d-adaa-a36350b7fbdb 61 fields · synced Oct 6, 2026