Pricing Sign in

Role
Country
Date of registration
Address

Made In Tracker

Made In Tracker EasyUDI

Legal

Privacy Policy Legal Notice

About

About FAQ Contact

Our data is continuously updated and sourced from EUDAMED, the European database for medical devices and in vitro diagnostics.

Subscribe to our monthly newsletter:

By subscribing, you accept the General Personal Data Protection Policy.

Organization name
UDI-DI code
Reference / catalog number

CYANCyte Reagent pack for 400 t — IVDD — General IVDD

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Apr 2, 2026

CYANCyte Reagent pack for 400 t

B-05404035101124

On the marketIVDD — General

Applicable legislation: IVDD [Directive 98/79/EC on in vitro diagnostic medical devices]
Organization name: Cypress Diagnostics
UDI-DI code: 05404035101124
Reference / catalog number: CY010-RP

Sign in to open the EUDAMED record

The link to the official EUDAMED page is reserved for signed-in users. Create a free account to continue.

Email

Password

No account yet?

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: CYANCyte Reagent pack for 400 t
UDI-DI code: 05404035101124
Basic UDI-DI: B-05404035101124
Reference / catalog number: CY010-RP
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: For in vitro diagnostic use by trained healthcare professionals only. This reagent pack contains the 3 reagents necessary for daily operation of the CYANCyte 560 automated hematology analyzer. The diluent is an isotonic saline solution, used to dilute the whole blood samples and as sheath fluid in the optical head. The lyse creates a hemolysate for the 5-part WBC differential and for HGB measurement. The cleaner is used for the cleaning process of the fluidics. This product is part of a closed system. It should only be used together with other CYANCyte 560 reagents and is only validated for use on the CYANCyte 560 analyzer. Erroneous results may be obtained if the product is used with third party reagents or analyzers
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

Batch number
Expiration date
Manufacturing date
Serial number
Software identification

Related devices

Acid solution54040351CY008-WSXQOn the market AlbuminB-05404035101209On the market Alkaline PhosphataseB-05404035101476On the market APTT (Act. Thromboplastine Time)B-05404035101636On the market ASOB-05404035101964On the market

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.