Manufacturer

CellaVision

SwedenLegal entities : CellaVision AB

Markets : Sweden · United States

Approvals : EU – class A, C · United States (FDA) – 510(k) : 7 · class I, II · latest in 2020 · see on the FDA website

3 categories, 15 models including 15 on the market, 1 country

Category	EMDN code	Registered models	Class	Contact
Various hematology / histology / cytology instruments - IVD medical device software	W02029092	Adv. RBC and Body Fluid Non-Expiring License3 refs Advanced RBC Application Non-Expiring License3 refs Body Fluid Application AG2417223 refs CellaVision® BMA Analyzer Software, for DC-1, version 1.0 CellaVision® Bone Marrow Aspirate Application CellaVision® BMA Review Software, version 1.0 CellaVision® Bone Marrow Aspirate Application 2 others CellaVision® DM Software DC-1 Version 7.13 refs CellaVision® Remote Review Double Edition3 refs	A, C IVDR	EUDAMED record Report an error
Various hematology / histology / cytology instruments - consumables	W02029085	CellaVision Oil Pack 2x150ml CellaVision ® Oil Pack 2 pcs Magazine Pack Body Fluids, Blue, 5 pcs Magazine Pack Peripheral Blood Orange 10 pcs	A IVDR	EUDAMED record Report an error
Various hematology / histology / cytology instruments - other	W02029099	Automated Digital Cell Morphology Analyzer DI-60 CellaVision® DC-1 CellaVision® DM1200 CellaVision® DM9600	A IVDR	EUDAMED record Report an error

A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.

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