Identity
- Trade Name
- HemoScreen EUDAMED
- Device Name
- HemoScreen EUDAMED
- Model / Reference
- HemoScreen 200 EUDAMEDHS-FA-30219 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07290016991109 EUDAMED
- Basic UDI-DI
- 7290016991HemoScreen200UW EUDAMED
- EMDN Code
- W0202010101 AUTOMATED WHOLE BLOOD HEMATOLOGY ANALYSERS - LOW ROUTINE (Throughput <= 100 samples/hr) EUDAMED
Classification
- Device Class
- Class B EUDAMED
- Market of Registration
- Spain EUDAMED
Clinical & Handling
Sterile
No
EUDAMED
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
HemoScreen by Pixcell Medical Ltd. — Class B — IVDR — listed in EUDAMED — regulatory data on deviCERTS
Authorization Coverage (European Union — 27 member states)
Regulatory Authorizations
European Union Active
CE/IVDR
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | CE/IVDR | 7290016991HemoScreen200UW | Class B | Active |
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Manufacturer
- Manufacturer
- Pixcell Medical Ltd.
- EUDAMED SRN
- IL-MF-000026612
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED 9137f3cf-0270-45bd-a436-73b1b225d015 61 fields · synced May 23, 2026