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

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Organization name
UDI-DI code
Reference / catalog number

Urine 2AC — IVDR Class B IVDR by Cypress Diagnostics

MD Atlas
Cypress Diagnostics

EUDAMED last updated this device on Jan 21, 2026

Urine 2AC

54040351URINE-2AC38

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: 05404035100646
Reference / catalog number: Urine-2AC

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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.

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

Device identification

Trade name: Urine 2AC
UDI-DI code: 05404035100646
Basic UDI-DI: 54040351URINE-2AC38
Reference / catalog number: Urine-2AC
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 Urine 2AC reagent strips are in vitro diagnostic medical device intended to be used for the qualitative or semi-quantitative determination of Microalbumin and Creatinine in human urine and further calculation of the Microalbumin to Creatinine ratio (ACR). The test can be read either visually or with the CYANStrip Mini analyzer. The determination of these parameters is intended to aid in the detection of microalbuminuria, which may indicate early kidney damage. 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

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