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Organization name
UDI-DI code
Reference / catalog number

CYANElite 290 — IVDR Class A IVDR by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Dec 4, 2023

CYANElite 290

54040351CY0155X

On the marketIVDR Class A

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Cypress Diagnostics
UDI-DI code: 05404035100295
Reference / catalog number: CY015

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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: CYANElite 290
UDI-DI code: 05404035100295
Basic UDI-DI: 54040351CY0155X
Reference / catalog number: CY015
Issuing entity: GS1

Classification

Risk category: IVDR Class A
Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Status: On the market

Device details

Quantity: 1
Additional product description: CYANElite 290 is a preprogrammed automated biochemistry analyzer with an uninterrupted work autonomy of up to 60 minutes. The CYANElite 290 can process up to 96 tests simultaneously. The analyzer performs a measurement every 25 seconds. This enables to run up to 145 tests per hour.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201010101CHEMISTRY ANALYSERS - LOW ROUTINE (Random access without ISE mode test/h <= 400)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

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Software identification