Identity
- Device Name
- FOX Food Explorer EUDAMED
- Model / Reference
- 80-5001-01 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 09120122928059 EUDAMED
- Basic UDI-DI
- B-09120122928059 EUDAMED
- EMDN Code
- W0102010105 IMMUNOGLOBULIN G EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Italy 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
No
EUDAMED
Category: Human immunoglobulin G (IgG) animal conjugate antibody reagent IVD
FOX Food Explorer by MacroArray Diagnostics — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDD
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDD | B-09120122928059 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- MacroArray Diagnostics
- EUDAMED SRN
- AT-MF-000030541
Sources (1)
- EUDAMED 57177cdc-f510-4b68-8cc1-6a8d02f9867a 61 fields · synced Oct 6, 2026