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(10C 3L) Navios EX Instrument
EUDAMEDFDA UDIClass A (EU MDR)
Ref B80910 Model Navios EX Instrument & Software
Identity
- Trade Name
- (10C 3L) Navios EX Instrument EUDAMEDNavios EX FDA UDI
- Generic Name
- Flow cytometry analyser IVD, semi-automated FDA UDI
- Device Name
- Navios EX Instrument & Software EUDAMEDNavios EX Flow Cytometer (10 Color/3 Laser) FDA UDI
- Model / Reference
- Navios EX Instrument & Software EUDAMEDB80910 EUDAMED10 Color 3 lasers FDA UDI
- Description
- Navios EX Flow Cytometer (10 Color/3 Laser) FDA UDI
Identifiers
- Catalog Number
- B80910 FDA UDI
- Primary DI / UDI-DI
- 15099590677466 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
- Flow cytometry analyser IVD, semi-automated 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
(10C 3L) Navios EX Instrument 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 0cfe74ef-0eb6-4ba5-a2cc-639888e1cc3b 61 fields · synced Jul 8, 2026
- FDA UDI f07eb52a-5274-4bd0-9ef1-de065ebe1495 35 fields · synced May 30, 2026