Identity
- Trade Name
- Galileo Echo EUDAMED
- Device Name
- Galileo Echo EUDAMED
- Model / Reference
- 0087000R EUDAMED
Identifiers
- Primary DI / UDI-DI
- 10888234001829 EUDAMED
- Basic UDI-DI
- 88823401W0202030102A001QH EUDAMED
- EMDN Code
- W0202030102 AUTOMATED BLOOD GROUPING ANALYSERS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Belgium 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
Yes
EUDAMED
New Device
No
EUDAMED
Galileo Echo by Immucor, Inc. — 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 | 88823401W0202030102A001QH | Class A | Active |
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Manufacturer
- Manufacturer
- Immucor, Inc.
- EUDAMED SRN
- US-MF-000011568
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (1)
- EUDAMED 26c7e510-d6d2-474b-85cc-50cf9624afe0 61 fields · synced May 22, 2026