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HemoScreen CBC Cartridge
EUDAMEDFDA UDIClass B (EU MDR)
Ref BC-MA-00300Model HemoScreen 200
Identity
- Trade Name
- HemoScreen CBC Cartridge EUDAMEDHemoScreen FDA UDI
- Generic Name
- Full blood count IVD, kit, cell count FDA UDI
- Device Name
- HemoScreen EUDAMEDA self-contained disposable unit in which a single blood sample is prepared and made ready for measurement and CBC analysis FDA UDI
- Model / Reference
- HemoScreen 200 EUDAMEDBC-MA-00300 EUDAMEDCBC Cartridge FDA UDI
- Description
- A self-contained disposable unit in which a single blood sample is prepared and made ready for measurement and CBC analysis FDA UDI
Identifiers
- Catalog Number
- BC-FA-00103 FDA UDI
- Primary DI / UDI-DI
- 07290016991017 EUDAMEDFDA UDI
- Basic UDI-DI
- 7290016991HemoScreen200UW EUDAMED
- 510(k) Number
- K180020 FDA UDI
- FDA Product Code
- GKZ FDA UDI
- EMDN Code
- W01030199,W0202010101 EUDAMED
- GMDN Term
- Full blood count IVD, kit, cell count FDA UDI
Classification
- Device Class
- Class B EUDAMEDClass II FDA UDI
- Regulation Number
- 864.5220 FDA UDI
- Market of Registration
- France 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
No
EUDAMED
Self Testing
No
EUDAMED
Near-Patient Testing
Yes
EUDAMED
Professional Testing
No
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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
Yes
FDA UDI
HemoScreen CBC Cartridge by Pixcell Medical Ltd. — Class B — 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 | 7290016991HemoScreen200UW | Class B | Active |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class B | Pending data |
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Manufacturer
- Manufacturer
- Pixcell Medical Ltd.
- EUDAMED SRN
- IL-MF-000026612
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (2)
- EUDAMED ea67f598-268d-40d7-8689-865ca6d1986e 61 fields · synced Jun 18, 2026
- FDA UDI e8b7fa4f-040d-4d7c-b822-7929bd514eef 37 fields · synced May 29, 2026