Skip to content

Chemiluminescence Analyzer Wash Buffer

by Maccura Biotechnology Co., Ltd.

Ref IM4409452Model 250 mL×2, 500 mL×2, 2 L×1, 2 L×2, 2 L×4, 5 L×1

Active European Union

CE IVDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number69506174IM440452DT Basic UDI-DI 06950617423690UDI-DIDate13 Feb 2025RegisteredStatusActive

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  • Withdrawn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
250 mL×2, 500 mL×2, 2 L×1, 2 L×2, 2 L×4, 5 L×1, IM4409452
Primary DI / UDI-DI
06950617423690
Basic UDI-DI
69506174IM440452DT
Direct Marketing DI
06950617423690
EMDN Code
W01029003 Buffers (unassignable), supplem. reagents, etc (ic)
Device Class
Class A
EU market of registration
Türkiye

Manufacturer details

EUDAMED SRN
CN-MF-000014618
Authorised representative
Humiss International B.V. NL-AR-000001490

Other devices from Maccura Biotechnology Co., Ltd.

See all devices from Maccura Biotechnology Co., Ltd. →

Properties

  • Reagent
  • Professional Testing

Other properties (9)

  • Sterile: No
  • Human Tissues: No
  • Animal Tissues: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No
  • New Device: No