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Cholesterol Reagent Kit(enzyme Method)

by Dirui Industrial Co., Ltd 8 variants

Ref 232012502008Model R1: 4x50mL, R2: 1x50mL,Calibration sample: 2mL

Cholesterol Reagent Kit(enzyme Method) (232012502008) is a device classified as IVD General made by Dirui Industrial Co., Ltd, registered in EUDAMED on 22 Jul 2026 (Basic UDI-DI B-06942202239885), active as of 24 Oct 2026.

Active European Union

CE IVDD

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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDD NumberB-06942202239885 Basic UDI-DI 06942202239885UDI-DIDate22 Jul 2026RegisteredStatusActive

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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / reference
R1: 4x50mL, R2: 1x50mL,Calibration sample: 2mL, 232012502008
Primary DI / UDI-DI
06942202239885
Basic UDI-DI
B-06942202239885
EMDN code
W01010205 Cholesterol
Device class
Class IVD General
EU registration type
Legacy device (under a directive)
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
CN-MF-000001891
Authorised representative
Emergo Europe B.V. NL-AR-000000116

Similar devices in this category

Other devices filed under CHOLESTEROL.

Other devices from Dirui Industrial Co., Ltd

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Properties

  • Contains animal tissues or cells
  • Contains substances of microbial origin
  • Reagent
  • IVD kit
  • Professional testing
Other properties (7, all answered No)