Identity
- Trade Name
- ClearLLab LS Lymphoid Screen Reagent EUDAMED
- Device Name
- ClearLLab LS Lymphoid Screen Reagent EUDAMED
- Model / Reference
- B74073 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590686567 EUDAMED
- Basic UDI-DI
- 150995906B74073UA EUDAMED
- EMDN Code
- W0103080101 ANTIBODIES FOR B AND T-CELL SUBTYPING EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Market of Registration
- Ireland 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
New Device
No
EUDAMED
ClearLLab LS Lymphoid Screen Reagent by Beckman Coulter India Private Limited — Class C — 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 | 150995906B74073UA | Class C | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter India Private Limited
- EUDAMED SRN
- IN-MF-000010115
- Authorised Representative
- Beckman Coulter Ireland Inc. IE-AR-000000886
Sources (1)
- EUDAMED f90efd67-07db-4000-b8d5-557d736ff4b3 61 fields · synced Jul 14, 2026