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SW Kit - SW Kit
EUDAMEDClass A (EU MDR)
Ref C54028Model Navios EX Instrument & Software
Identity
- Trade Name
- SW Kit; Navios New User (Win 10) EUDAMED
- Device Name
- Navios EX Instrument & Software EUDAMED
- Model / Reference
- Navios EX Instrument & Software EUDAMEDC54028 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 15099590738228 EUDAMED
- Basic UDI-DI
- 150995902LSFlowCytomet8B EUDAMED
- EMDN Code
- W0202040182 CYTOFLOWMETERS - SOFTWARE ACCESSORIES EUDAMED
- Models / Variants
- SW Kit EUDAMEDNavios New User (Win 10) EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
SW Kit - SW Kit by Beckman Coulter Ireland Inc. — Class A — IVDR — listed in EUDAMED — 2 models — 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 | 150995902LSFlowCytomet8B | Class A | Active |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (1)
- EUDAMED d107488d-cae5-432f-88c4-46dc3f7ea81a 61 fields · synced Oct 6, 2026