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Organization name
UDI-DI code
Reference / catalog number

Cleaning solution — IVDR Class A IVDR by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Dec 4, 2023

Cleaning solution

54040351CY008-WSXQ

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: 05404035100356
Reference / catalog number: CY008-WS-III

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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.

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

Device identification

Trade name: Cleaning solution
UDI-DI code: 05404035100356
Basic UDI-DI: 54040351CY008-WSXQ
Reference / catalog number: CY008-WS-III
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: "- The Cleaning solution removes any reaction liquid residuum from the cuvettes during the washing cycle of the CYANExpert 130 instrument. - Cleaning solution does not interfere with any reagent used during instrument operation. - Please refer to the instrument’s User Manual for further information. - For professional and in vitro diagnostic use only (IVD)"
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0201010185CHEMISTRY ANALYSERS - CONSUMABLES

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

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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.