Identity
- Trade Name
- AQUIOS CL Flow Cytometer EUDAMEDAQUIOS FDA UDI
- Generic Name
- Flow cytometry analyser IVD, semi-automated FDA UDI
- Device Name
- Aquios Instrument EUDAMEDAQUIOS CL Flow Cytometer FDA UDI
- Model / Reference
- B30166 EUDAMEDCL FDA UDI
- Description
- AQUIOS CL Flow Cytometer FDA UDI
Identifiers
- Catalog Number
- B30166 FDA UDI
- Primary DI / UDI-DI
- 15099590225889 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902FlowCytometerRJ EUDAMED
- FDA Product Code
- OYE FDA UDI
- EMDN Code
- W0202040102 CYTOFLOWMETERS - MODERATE ROUTINE 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
AQUIOS CL Flow Cytometer 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 | 150995902FlowCytometerRJ | 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 74da0e22-b542-4c21-b64f-f924cacc96b4 61 fields · synced May 30, 2026
- FDA UDI f287ac93-380e-417b-97ec-ddc4e106673c 34 fields · synced May 30, 2026