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Flow Set Pro Fluorospheres
EUDAMEDFDA UDIClass C (EU MDR)
Ref A63492Model Flow Set Pro Fluorospheres
Identity
- Trade Name
- Flow Set Pro Fluorospheres EUDAMEDFlow Set Pro (RUO A69184) FDA UDI
- Generic Name
- Non-blood cell primer/calibrator/control material IVD, reagent FDA UDI
- Device Name
- Flow-Set Pro Fluorospheres FDA UDI
- Model / Reference
- Flow Set Pro Fluorospheres EUDAMEDA63492 EUDAMEDFDA UDI
- Description
- Flow-Set Pro Fluorospheres FDA UDI
Identifiers
- Catalog Number
- A63492 FDA UDI
- Primary DI / UDI-DI
- 15099590205775 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902FCFLUROSPHRSAH EUDAMED
- 510(k) Number
- K130373 FDA UDI
- FDA Product Code
- PDX FDA UDI
- EMDN Code
- W0103080401 SETUP BEADS EUDAMED
- GMDN Term
- Non-blood cell primer/calibrator/control material IVD, reagent FDA UDI
Classification
- Device Class
- Class C EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 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
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
Flow Set Pro Fluorospheres by Beckman Coulter Ireland Inc. — Class C — 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 | 150995902FCFLUROSPHRSAH | Class C | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class C | Pending data |
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Manufacturer
- Manufacturer
- Beckman Coulter Ireland Inc.
- EUDAMED SRN
- IE-MF-000000887
Sources (2)
- EUDAMED c8795a29-bc3b-4863-bbd5-10e370e43247 61 fields · synced Jun 19, 2026
- FDA UDI 20cdd334-59fe-49cf-8c9e-7e2bacbafa18 35 fields · synced May 29, 2026