← Back to catalogue
HemoScreen CBC Sampler
EUDAMEDClass A (EU MDR)
Ref BC-MA-00100Model HemoScreen200
Identity
- Trade Name
- HemoScreen CBC Sampler EUDAMED
- Device Name
- HemoScreen EUDAMED
- Model / Reference
- HemoScreen200 EUDAMEDBC-MA-00100 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 27290016991073 EUDAMED
- Basic UDI-DI
- 7290016991HS200Accessor7G EUDAMED
- EMDN Code
- W0501010202 CAPILLARY AND VENOUS BLOOD COLLECTION, INTEGRATED SYSTEMS EUDAMED
Classification
- Device Class
- Class A EUDAMED
- Market of Registration
- Denmark 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 CBC Sampler by Pixcell Medical Ltd. — Class A — 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 | 7290016991HS200Accessor7G | Class A | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Pixcell Medical Ltd.
- EUDAMED SRN
- IL-MF-000026612
- Authorised Representative
- CEpartner4U NL-AR-000000111
Sources (1)
- EUDAMED d7b76f80-82ee-46f9-9fa9-d6d951b48649 61 fields · synced Jul 14, 2026