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CellaVision® BMA Analyzer Software, for DC-1, version 1.0
EUDAMEDClass C (EU MDR)
Ref CBMA-A0110Model CellaVision® Bone Marrow Aspirate Application
Identity
- Trade Name
- CellaVision® BMA Analyzer Software, for DC-1, version 1.0 EUDAMED
- Device Name
- CellaVision® BMA Analyzer Software EUDAMED
- Model / Reference
- CellaVision® Bone Marrow Aspirate Application EUDAMEDCBMA-A0110 EUDAMED
Identifiers
- Primary DI / UDI-DI
- 07350040977460 EUDAMED
- Basic UDI-DI
- 735004097CBMA-AXN EUDAMED
- Direct Marketing DI
- 07350040977460 EUDAMED
- EMDN Code
- W02029092 VARIOUS HEMATOLOGY / HISTOLOGY / CYTOLOGY INSTRUMENTS - IVD MEDICAL DEVICE SOFTWARE EUDAMED
Classification
- Device Class
- Class C EUDAMED
- Special Device Type
- Software EUDAMED
- Market of Registration
- Sweden 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
No
EUDAMED
Professional Testing
Yes
EUDAMED
Companion Diagnostics
No
EUDAMED
Surgical Instrument
Yes
EUDAMED
New Device
No
EUDAMED
CellaVision® BMA Analyzer Software, for DC-1, version 1.0 by Cellavision AB — Class C — 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 | 735004097CBMA-AXN | Class C | Active |
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Manufacturer
- Manufacturer
- CellaVision AB
- EUDAMED SRN
- SE-MF-000002377
Sources (1)
- EUDAMED a23669e3-4264-4baf-98e8-c59af59c5776 61 fields · synced Jun 18, 2026