Identity
- Trade Name
- ClearLLab Compensation Kit EUDAMED
- Device Name
- ClearLLab Compensation Kit EUDAMED
- Model / Reference
- B74074 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590686574 EUDAMED
- Basic UDI-DI
- 150995906B74074UC 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 Compensation Kit 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 | 150995906B74074UC | 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 ee831f97-c8b5-4179-86be-2e3dc687ae9a 61 fields · synced Jul 11, 2026