Identity
- Trade Name
- Grifols sCD38 EUDAMED
- Device Name
- Grifols sCD38 EUDAMED
- Model / Reference
- Grifols sCD38 EUDAMED213686 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640137341589 EUDAMED
- Basic UDI-DI
- 764013734sCD38HG EUDAMED
- Direct Marketing DI
- 07640137341589 EUDAMED
- EMDN Code
- W01030399 IMMUNOHAEMATOLOGY (BLOOD GROUPING) TESTS - OTHER EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Grifols sCD38 by Medion Grifols Diagnostics Ag — Class B — 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 | 764013734sCD38HG | Class B | 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 (2)
- EUDAMED be0fc4b1-c9a8-4f18-b54b-bca33d518039 61 fields · synced Jul 20, 2026
- EUDAMED 5fb95d3e-9d87-4e16-93b0-b24ce4a2829b 61 fields · synced Jul 20, 2026