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Organization name
UDI-DI code
Reference / catalog number

CYDXStrips Urine 2GP — IVDR Class B IVDR by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Jan 21, 2026

CYDXStrips Urine 2GP

54040351CYDXStripsWH

On the marketIVDR Class B

Applicable legislation: IVDR [Regulation (EU) 2017/746 on in vitro diagnostic medical devices]
Organization name: Cypress Diagnostics
UDI-DI code: 05404035100622
Reference / catalog number: Urine-2GP

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Manufacturer information

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

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.

Country	On market since	Until
BelgiumPrimary placement	Jan 12, 2026	Still on market

Device identification

Trade name: CYDXStrips Urine 2GP
UDI-DI code: 05404035100622
Basic UDI-DI: 54040351CYDXStripsWH
Reference / catalog number: Urine-2GP
Issuing entity: GS1

Classification

Risk category: IVDR Class B
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 Cypress Diagnostics CYDXStrips, are an in vitro diagnostic medical device intended to be used for the qualitative or semi-quantitative determination of Urobilinogen, Glucose, Bilirubin, Ketones (Acetoacetic Acid), Specific Gravity, Blood, pH, Protein, Nitrite and Leukocytes in human urine. The test can be read either visually or with the CYANStrip Mini analyzer. The determination of these parameters is intended to be used to aid in the diagnosis of metabolic, renal, hepatic, urinary tract or systemic diseases and disorders in patients showing typical symptoms of the mentioned disorders. This kit is intended to be used by healthcare professionals in a laboratory-based testing environment. Not for self-testing. For in vitro diagnostic use only. For professional use only.
Additional information URL: No additional information URL provided by the manufacturer.
Clinical sizes: No clinical sizes registered for this device.

EMDN nomenclature code(s)

W0101060204URINE MULTI-CONSTITUENT TEST STRIPS (MANUAL)

Compliance flags

Safety

Sterile

Single use

Direct marking

Regulatory

Sterilization

Lifecycle

New device

UDI-PI traceability

Batch number
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Software identification

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