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SW offline New user (Navios EX)
EUDAMEDFDA UDIClass A (EU MDR)
Ref B91238Model Navios EX Instrument & Software
Identity
- Trade Name
- SW offline New user (Navios EX) EUDAMEDNavios EX FDA UDI
- Generic Name
- Laboratory instrument/analyser application software IVD FDA UDI
- Device Name
- Navios EX Instrument & Software EUDAMEDNAVIOS EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7 FDA UDI
- Model / Reference
- Navios EX Instrument & Software EUDAMEDB91238 EUDAMEDOFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7 FDA UDI
- Description
- NAVIOS EX OFFLINE ACQ SINGLE USER SOFTWARE V2.0 WIN 7 FDA UDI
Identifiers
- Catalog Number
- B91238 FDA UDI
- Primary DI / UDI-DI
- 15099590683252 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902LSFlowCytomet8B EUDAMED
- 510(k) Number
- K162897 FDA UDI
- FDA Product Code
- OYE FDA UDI
- EMDN Code
- W0202040182 CYTOFLOWMETERS - SOFTWARE ACCESSORIES EUDAMED
- GMDN Term
- Laboratory instrument/analyser application software IVD FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Special Device Type
- Software EUDAMED
- Market of Registration
- Ireland 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
SW offline New user (Navios EX) by Beckman Coulter Ireland 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 | 150995902LSFlowCytomet8B | Class A | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class A | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (2)
- EUDAMED 79a3b58b-b314-4eb0-8845-105e13500bed 61 fields · synced Jul 9, 2026
- FDA UDI e24fd550-bc5e-427f-bfee-89ca1b11bd7e 35 fields · synced May 30, 2026