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Interleukin-6 Chemiluminescence Immunoassay Kit

EUDAMED

Class IVD General (EU MDR)

Ref S2035E-25Ref S2036E-100Ref S2035E-200Ref S2035E-75

by Sansure Biotech Inc.

Identity

Device Name
Interleukin-6 Chemiluminescence Immunoassay Kit EUDAMED
Interleukin-8 Chemiluminescence Immunoassay Kit EUDAMED
Model / Reference
S2035E-25 EUDAMED
S2036E-100 EUDAMED
S2035E-200 EUDAMED
S2035E-75 EUDAMED

Identifiers

Primary DI / UDI-DI
06955792738928 EUDAMED
06955792739017 EUDAMED
06955792738973 EUDAMED
06955792738942 EUDAMED
Basic UDI-DI
B-06955792738928 EUDAMED
B-06955792739017 EUDAMED
B-06955792738973 EUDAMED
B-06955792738942 EUDAMED
EMDN Code
W01030609 INTERLEUKIN 6 (IL-6) EUDAMED
W01030606 OTHER INTERLEUKINS (EXCEPT FOR IL-6) EUDAMED

Classification

Device Class
Class IVD General EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

Yes

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

Interleukin-6 Chemiluminescence Immunoassay Kit by Sansure Biotech Inc. — 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-000011392
Authorised Representative
Obelis s.a. BE-AR-000000106

Sources (4)

  • EUDAMED dcfed1f4-395d-4dc4-b332-bc46cb41f6d1 61 fields · synced Jul 26, 2026
  • EUDAMED 4b7a63f1-be05-4725-a0ea-6425fe43d09e 61 fields · synced May 18, 2026
  • EUDAMED 0b9ac045-5d66-4e5b-a993-b8e19c1fc0de 61 fields · synced May 18, 2026
  • EUDAMED 7c03608d-c6af-4bbc-947e-931d1cba6f58 61 fields · synced May 18, 2026