Identity
- Trade Name
- Enlisst-II EUDAMED
- Device Name
- Enlisst-II EUDAMED
- Model / Reference
- Enlisst-II EUDAMED213577 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07640137341077 EUDAMED
- Basic UDI-DI
- 764013734Enlisst-IIMH EUDAMED
- Direct Marketing DI
- 07640137341077 EUDAMED
- EMDN Code
- W0103030306 ENHANCEMENT MEDIA (E.G. BOVINE ALBUMIN, LISS, PEG) EUDAMED
Classification
- Device Class
- Class A 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
Enlisst-II by Medion Grifols Diagnostics Ag — 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 | 764013734Enlisst-IIMH | Class A | 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 7090733d-5bb6-4c1d-89fa-48559a4f8f94 61 fields · synced Aug 2, 2026
- EUDAMED 8b0e8c75-7f2c-4257-85b4-5c2eff00469a 61 fields · synced Aug 2, 2026