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Organization name
UDI-DI code
Reference / catalog number

CYANCoag 1Ch — IVDR Class A IVDR by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Dec 4, 2023

CYANCoag 1Ch

54040351CY0035Q

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: 05404035100318
Reference / catalog number: CY003

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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: CYANCoag 1Ch
UDI-DI code: 05404035100318
Basic UDI-DI: 54040351CY0035Q
Reference / catalog number: CY003
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: CYANCoag coagulometer is an up-to-date, processor controlled semiautomatic mechanical measuring instrument for - in vitro - diagnostic blood coagulation analysis. The measuring system determines the clotting time of whole blood, citrated capillary blood or blood plasma by using the effect of a change in viscosity when the clotting starts. The system monitors the reaction progress during the analysis and indicates critical results to the user. The automatic checking of the CYANCoag eliminates the need for servicing and setting. A minimum sample volume of only 150µl allows using the economical micro volume method. Its compact design and simple handling make the CYANCoag an effective coagulometer.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0202020101SEMI-AUTOMATED COAGULOMETERS

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

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