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Organization name
UDI-DI code
Reference / catalog number

Diluent 20L — IVDD — General IVDD by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Mar 30, 2026

Diluent 20L

B-05404035100523

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cypress Diagnostics
UDI-DI code: 05404035100523
Reference / catalog number: CY006-R01

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Manufacturer information

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

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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.

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.

Placed on the market in Belgium; per-country availability dates not published.

Device identification

Trade name: Diluent 20L
UDI-DI code: 05404035100523
Basic UDI-DI: B-05404035100523
Reference / catalog number: CY006-R01
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: Diluent is a buffered, stabilized and micro-filtered electrolyte solution for automated dilution of human blood samples, quantitative and qualitative determination of blood cells (erythrocytes (RBC), leukocytes (WBC) and the leukocyte subpopulations and thrombocytes (PLT)) as well as the measurement of hemoglobin (HGB) concentration on the CYANHemato/CYANHemato 380 analyzer. The diluent reagent should only be used together with other CYANHemato/CYANHemato 380 reagents. Erroneous results may be obtained if the reagent is used with third party reagents. Furthermore, this reagent is only validated for use on the CYANHemato/CYANHemato 380 analyser. Please refer to the instrument’s user manual for further information.
Additional information URL: https://www.diagnostics.be/
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0103010105CBC-REAGENTS (CLEANING-/DILUTING-/LYSING-/SHEAT-FLUIDS)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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