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Chemiluminescence Analyzer

by Rayto Life and Analytical Sciences Co., Ltd. 5 variants

Ref Lumiray 680, Lumiray 650, Lumiray 670, Lumiray 4080, Lumiray 1600, Lumiray 600

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 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number694702440219666 Basic UDI-DI Date25 Apr 2022RegisteredStatusActive

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  • Withdrawn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
Lumiray 680, Lumiray 650, Lumiray 670, Lumiray 4080, Lumiray 1600, Lumiray 600
Primary DI / UDI-DI
06947024409690, 06947024412836, 06947024412843, 06947024411976, 06947024409713, 06947024409676
Basic UDI-DI
694702440219666, 69470244021725Q, 694702440218969, 694702440983688, 69470244013665Y, 69470244021415D
Direct Marketing DI
06947024409690
06947024412836
06947024412843
06947024411976
06947024409713
06947024409676
EMDN Code
W0201020101, W0201020103, W0201020102
Device Class
Class A
EU market of registration
Ireland
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000011141
Authorised representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

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Properties

  • Professional Testing NoEUDAMEDYesEUDAMED
  • Surgical Instrument

Other properties (9)

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