Identity
- Trade Name
- Neutr-AB II EUDAMED
- Device Name
- Neutr-AB II EUDAMED
- Model / Reference
- Neutr-AB II EUDAMED213424 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640137341145 EUDAMED
- Basic UDI-DI
- B-07640137341145 EUDAMED
- EMDN Code
- W0103030399 ANTIBODY DETECTION (IMMUNOHAEMATOLOGY) - OTHER EUDAMED
Classification
- Device Class
- Class IVD General EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
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
Neutr-AB II by Medion Grifols Diagnostics Ag — 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-07640137341145 | Class IVD General | Active |
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Manufacturer
- Manufacturer
- Medion Grifols Diagnostics AG
- EUDAMED SRN
- CH-MF-000024272
- Authorised Representative
- Diagnostic Grifols, S.A. ES-AR-000001573
Sources (1)
- EUDAMED a9657aaf-1457-4ad4-845d-b17aa7340888 61 fields · synced Jun 19, 2026