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Hokapi™ Il-6

EUDAMED

Class C (EU MDR)

Ref 011002601Ref 011002101

by Suzhou Hokapi Biomedical Engineering Co., Ltd..

Identity

Trade Name
HOKAPI™ IL-6 EUDAMED
Device Name
HOKAPI™ IL-6 EUDAMED
Model / Reference
011002601 EUDAMED
011002101 EUDAMED

Identifiers

Primary DI / UDI-DI
06939716405288 EUDAMED
06971390439982 EUDAMED
Basic UDI-DI
69713904310027D EUDAMED
Direct Marketing DI
06939716405288 EUDAMED
06971390439982 EUDAMED
EMDN Code
W01030609 INTERLEUKIN 6 (IL-6) EUDAMED

Classification

Device Class
Class C EUDAMED
Market of Registration
France 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

New Device

No

EUDAMED

Hokapi™ Il-6 by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class C — IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDR

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Manufacturer

EUDAMED SRN
CN-MF-000013723
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (2)

  • EUDAMED a1f46010-24b4-454a-83bd-043115c8cd9a 61 fields · synced Jul 21, 2026
  • EUDAMED 7439fc75-98f7-4674-ac3f-d27eb1cbc98d 61 fields · synced May 19, 2026