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Organization name
UDI-DI code
Reference / catalog number

CYANHemato 380 — IVDD — General IVDD by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Apr 2, 2026

CYANHemato 380

B-05404035100486

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cypress Diagnostics
UDI-DI code: 05404035100486
Reference / catalog number: CY017

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Manufacturer information

Organization name: Cypress Diagnostics
SRN: BE-MF-000000033
Manufacturer status: Active

Critical warnings

1 warning recorded — scroll inside the panel to see all entries.

CW010
See IFU

Market distribution

Primary placement in Belgium; available across 1 country total.

Country	On market since	Until
BelgiumPrimary placement		Still on market

Device identification

Trade name: CYANHemato 380
UDI-DI code: 05404035100486
Basic UDI-DI: B-05404035100486
Reference / catalog number: CY017
Issuing entity: GS1

Classification

Risk category: IVDD — General
Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: The CYANHemato 380 (CY017) is an easy to operate, fully automated bench top hematology analyzer designed for in vitro diagnostic testing. It is intended to be used by trained healthcare professionals only, in clinical laboratories. The analyzer is a 3-part differential analyzer. It measures and evaluates the complete blood count (CBC) and differentiates the white blood cells in three populations: the lymphocytes, the mid-sized cells (reflecting monocytes) and the granulocytes (reflecting neutrophils, eosinophils, and basophils). The analyzer combines different techniques to analyze the whole blood samples: electrical impedance and spectrophotometry. The analyzer is intended to be used for the quantitative measurement and determination of the following 20 parameters in open vials with K2 or K3 EDTA-anticoagulated human venous whole blood samples: WBC, LYM, LYM%, MID, MID%, GRA, GRA%, HGB, RBC, MCV, HCT, MCH, MCHC, RDW, PLT, MPV, PCT, PDW, PLCC, PLCR. The CYANHemato 380 measures these hematologic parameters within and outside established reference ranges. The results provided by the CYANHemato 380 are for the evaluation of the patient's overall health (screening) and as an aid to diagnose and monitor a wide range of blood-related disorders.
Additional information URL: https://www.diagnostics.be/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202010201AUTOMATED 3 PART HEMATOLOGY ANALYSERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Certificates

No certificates registered for this manufacturer.

No certificate references this Basic UDI-DI, because: • It does not require a certificate, or • It only requires a certificate without a Basic UDI-DI reference (e.g. a QMS certificate), or • The required certificate(s) referencing this Basic UDI-DI have not been registered yet.