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CYANStrip Mini

by Cypress Diagnostics

Ref CY011

CYANStrip Mini (CY011) is an in vitro diagnostic device (EU IVDR Class A; EMDN category urine strip readers) made by Cypress Diagnostics, registered in EUDAMED on 4 Dec 2023 (Basic UDI-DI 54040351CY0115P), active as of 22 Oct 2026.

Active European Union

CE IVDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number54040351CY0115P Basic UDI-DI 05404035100271UDI-DIDate4 Dec 2023RegisteredStatusActive

Official records

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/IVDR Active

Specification

EUDAMED

Model / reference
CY011
Primary DI / UDI-DI
05404035100271
Basic UDI-DI
54040351CY0115P
Direct marketing DI
05404035100271
EMDN code
W020101020101 Urine strip readers
Device class
Class A
EU registration type
Standard device
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
BE-MF-000000033

Similar devices in this category

Other devices filed under URINE ANALYSERS.

Other devices from Cypress Diagnostics

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Properties

  • Professional testing
  • IVD instrument
Other properties (11, all answered No)