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Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay)

EUDAMED

Class IVD General (EU MDR)

Ref 3010671Model 1×50 Tests/kitRef 3013891Model 2×50 Tests/kit

by Dirui Industrial Co., Ltd

Identity

Trade Name
Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Device Name
Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay) EUDAMED
Model / Reference
1×50 Tests/kit EUDAMED
3010671 EUDAMED
2×50 Tests/kit EUDAMED
3013891 EUDAMED

Identifiers

Primary DI / UDI-DI
06925794518361 EUDAMED
06942202224201 EUDAMED
Basic UDI-DI
B-06925794518361 EUDAMED
B-06942202224201 EUDAMED
EMDN Code
W01030609 INTERLEUKIN 6 (IL-6) EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
Austria 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

Human Interleukin-6 Detection Kit (Chemiluminescence Immunoassay) by Dirui Industrial Co., Ltd — Class IVD General — IVDD — listed in EUDAMED

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

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Manufacturer

EUDAMED SRN
CN-MF-000001891
Authorised Representative
Emergo Europe B.V. NL-AR-000000116

Sources (2)

  • EUDAMED 0c5545c4-2cbb-45f7-8d2d-bcdcc63252d2 61 fields · synced Jul 24, 2026
  • EUDAMED d6a315da-69ab-4218-a54b-2e7ab200e4b2 61 fields · synced May 17, 2026