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Flow-Check Pro Fluorospheres
EUDAMEDFDA UDIClass A (EU MDR)
Ref A63493Model Flow-Check Pro Fluorospheres
Identity
- Trade Name
- Flow-Check Pro Fluorospheres EUDAMEDFlow Check Pro FDA UDI
- Generic Name
- Non-blood cell primer/calibrator/control material IVD, reagent FDA UDI
- Device Name
- Flow-Check Pro Fluorospheres EUDAMEDFDA UDI
- Model / Reference
- Flow-Check Pro Fluorospheres EUDAMEDA63493 EUDAMEDFDA UDI
- Description
- Flow-Check Pro Fluorospheres FDA UDI
Identifiers
- Primary DI / UDI-DI
- 15099590205782 EUDAMEDFDA UDI
- Basic UDI-DI
- 150995902LSFLOWCHECKHZ EUDAMED
- FDA Product Code
- PPM 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 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
No
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
Yes
FDA UDI
Flow-Check Pro Fluorospheres 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 | 150995902LSFLOWCHECKHZ | 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 c3db37ca-b3ce-4225-88d4-2eea93a6361b 61 fields · synced Oct 6, 2026
- FDA UDI 9b990f96-61d3-4edc-91f9-ba0d9776022a 33 fields · synced May 30, 2026