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Reagent Containers

by Cypress Diagnostics

Ref CY012-C02Model CY012-C01-02

Reagent Containers (CY012-C02) is an in vitro diagnostic device (EU IVDR Class A; EMDN category coagulometers - consumables) made by Cypress Diagnostics, registered in EUDAMED on 4 Dec 2023 (Basic UDI-DI 54040351CY012-CT7), 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 Number54040351CY012-CT7 Basic UDI-DI 05404035100424UDI-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  • Withdrawn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

Device name
Consumables for CYANCoag 2CH
Model / reference
CY012-C01-02, CY012-C02
Primary DI / UDI-DI
05404035100424
Basic UDI-DI
54040351CY012-CT7
Direct marketing DI
05404035100424
EMDN code
W0202020185 Coagulometers - consumables
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 COAGULOMETERS - CONSUMABLES.

Other devices from Cypress Diagnostics

See all devices from Cypress Diagnostics →

Properties

  • IVD kit
  • Professional testing
  • IVD instrument
Other properties (10, all answered No)