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Sharay Cytokine Profile (CLIA)

EUDAMED

Class IVD General (EU MDR)

Ref 18327001 Model Model 8: Sharay IL-12p70

by C-Luminary Biotechnology Co., Ltd.

Identity

Trade Name
Sharay Cytokine Profile (CLIA) EUDAMED
Device Name
Sharay Cytokine Profile (CLIA) EUDAMED
Model / Reference
18327001 EUDAMED
Model 8: Sharay IL-12p70 EUDAMED

Identifiers

Primary DI / UDI-DI
06975070762704 EUDAMED
Basic UDI-DI
B-06975070762704 EUDAMED
EMDN Code
W01030606 OTHER INTERLEUKINS (EXCEPT FOR IL-6) EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Germany EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

No

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

No

EUDAMED

Near-Patient Testing

No

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

No

EUDAMED

Surgical Instrument

No

EUDAMED

Sharay Cytokine Profile (CLIA) by C-Luminary Biotechnology Co., Ltd. — Class IVD General — IVDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

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

Sources (2)

  • EUDAMED 27bded6c-2af1-4c14-9297-5630b3c0af53 61 fields · synced Jun 18, 2026
  • EUDAMED bf2c8e95-bbe9-445e-a18a-6534332d38d1 61 fields · synced Jun 11, 2026