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Sharay Specific IgE (Mixed Allergens 2) (CLIA)

by C-Luminary Biotechnology Co., Ltd. 14 variants

Ref 14000708Model Model 3: Tree pollen Tx13, 100 Tests/Kit

Active European Union

CE IVDD

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/IVDD NumberB-06975070768232 Basic UDI-DI 06975070768232UDI-DIDate25 May 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  • Withdrawn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/IVDD Active

Specification

EUDAMED

Model / Reference
Model 3: Tree pollen Tx13, 100 Tests/Kit, 14000708
Primary DI / UDI-DI
06975070768232
Basic UDI-DI
B-06975070768232
EMDN Code
W01020202 Immunoglobulin e - specific, monotest/monoresult
Device Class
Class IVD General
EU market of registration
Ireland

Manufacturer details

EUDAMED SRN
CN-MF-000035089
Authorised representative
Sungo Cert GmbH DE-AR-000010869

Related devices

Category: Allergen-specific immunoglobulin E (IgE) antibody IVD, reagent

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

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Properties

  • Human Tissues
  • Animal Tissues
  • Reagent
  • Professional Testing

Other properties (6)

  • Sterile: No
  • Microbial Substances: No
  • Self Testing: No
  • Near-Patient Testing: No
  • Companion Diagnostics: No
  • Surgical Instrument: No