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Flow Clean
EUDAMEDFDA UDIClass A (EU MDR)
Ref A64669Model Flow Cytometer Cleaning Reagents
Identity
- Trade Name
- Flow Clean EUDAMEDFDA UDI
- Generic Name
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
- Device Name
- Flow Clean EUDAMEDFlow Clean Cleaning Agent FDA UDI
- Model / Reference
- Flow Cytometer Cleaning Reagents EUDAMEDA64669 EUDAMEDFDA UDI
- Description
- Flow Clean Cleaning Agent FDA UDI
Identifiers
- Catalog Number
- A64669 FDA UDI
- Primary DI / UDI-DI
- 15099590205843 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902FLOWCLEANNL EUDAMED
- FDA Product Code
- JCB FDA UDI
- EMDN Code
- W0103080699 REAGENTS FOR FLOW CYTOMETRY - OTHER EUDAMED
- GMDN Term
- Wash/cleaning solution IVD, automated/semi-automated system FDA UDI
Classification
- Device Class
- Class A EUDAMEDClass I FDA UDI
- Regulation Number
- 864.4010 FDA UDI
- Market of Registration
- Ireland EUDAMED
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Human Tissues
No
EUDAMED
Animal Tissues
No
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
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
Yes
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Flow Clean 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 | 150995902FLOWCLEANNL | 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 16560ba6-578d-4ee1-8d44-18b7ef65b132 61 fields · synced Oct 6, 2026
- FDA UDI 90d6b2f2-b3e9-4c8e-9b26-082953c13d98 35 fields · synced May 26, 2026