Identity
- Trade Name
- ECHO Lumena EUDAMEDFDA UDI
- Generic Name
- Immunohaematology/blood bank analyser IVD FDA UDI
- Device Name
- ECHO Lumena EUDAMEDThe Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data management functions. The Echo Lumena is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping. FDA UDI
- Model / Reference
- 0086998 EUDAMEDFDA UDI
- Description
- The Echo Lumena is a microprocessor-controlled instrument designed to fully automate immunohematology in vitro diagnostic testing of human blood. The Echo Lumena automates test processing, result interpretation, and data management functions. The Echo Lumena is designed to automate standard immunohematology assays using a microstrip-based platform. Assays include ABO and Rh (D) typing, detection/identification of IgG red blood cell antibodies, compatibility testing, and red blood cell phenotyping. FDA UDI
Identifiers
- Catalog Number
- 0086998 FDA UDI
- Primary DI / UDI-DI
- 10888234002338 EUDAMEDFDA UDI
- Basic UDI-DI
- 88823401W0202030102A000QF EUDAMED
- FDA Product Code
- KSZ FDA UDI
- EMDN Code
- W0202030102 AUTOMATED BLOOD GROUPING ANALYSERS EUDAMED
- GMDN Term
- Immunohaematology/blood bank analyser IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.9175 FDA UDI
- Market of Registration
- Belgium EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
ECHO Lumena by Immucor, Inc. — Class A — IVDR, FDA UDI — listed in EUDAMED, FDA GUDID — regulatory data on deviCERTS
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Active
CE/IVDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 88823401W0202030102A000QF | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Immucor, Inc.
- EUDAMED SRN
- US-MF-000011568
- Authorised Representative
- IMMUCOR Medizinische Diagnostik GmbH DE-AR-000007083
Sources (2)
- EUDAMED 0644ae0a-ec12-47cd-aeb4-69d6d4cc4f26 61 fields · synced Jul 26, 2026
- FDA UDI cf9b8944-69a2-44a4-8bb9-fd723d5bc91a 37 fields · synced May 29, 2026