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Sharay Specific IgE Magnetic Beads (M) and Conjugate (R2)

by C-Luminary Biotechnology Co., Ltd.

Ref 14001058Model 200 Tests/kit

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/IVDR Number697507076000340RX Basic UDI-DI 06980070461755UDI-DIDate3 Sep 2026RegisteredStatusActive

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  • Withdrawn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
200 Tests/kit, 14001058
Primary DI / UDI-DI
06980070461755
Basic UDI-DI
697507076000340RX
EMDN Code
W01020202 Immunoglobulin e - specific, monotest/monoresult
Device Class
Class A
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000035089
Authorised representative
Share info GmbH DE-AR-000005132

Other devices from C-Luminary Biotechnology Co., Ltd.

See all devices from C-Luminary Biotechnology Co., Ltd. →

Properties

  • Animal Tissues
  • Microbial Substances
  • Reagent
  • Professional Testing
  • Companion Diagnostics

Other properties (6)

  • Sterile: No
  • Human Tissues: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Surgical Instrument: No
  • New Device: No