Identity
- Device Name
- FITC/EVANS (R) EUDAMED
- Model / Reference
- 44590 EUDAMED44836 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 08435287145908 EUDAMED08435287148367 EUDAMED
- Basic UDI-DI
- B-08435287145908 EUDAMEDB-08435287148367 EUDAMED
- EMDN Code
- W01029099 IMMUNOCHEMISTRY REAGENTS - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
Yes
EUDAMEDEUDAMED
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
Fitc/Evans (r) by Biosystems S.a. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS
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-08435287145908 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Biosystems S.a.
- EUDAMED SRN
- ES-MF-000000231
Sources (2)
- EUDAMED 67d21699-82d1-4330-b63f-257945e8aca6 61 fields · synced Jul 13, 2026
- EUDAMED d5be603d-614b-435b-8d95-756bec3f4a23 61 fields · synced May 19, 2026