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Hokapi™ Ferritin

EUDAMED

Class B (EU MDR)

Ref 010901001Ref 010901101Ref 010901601

by Suzhou Hokapi Biomedical Engineering Co., Ltd..

Identity

Trade Name
HOKAPI™ FERRITIN EUDAMED
Device Name
HOKAPI™ FERRITIN EUDAMED
Model / Reference
010901001 EUDAMED
010901101 EUDAMED
010901601 EUDAMED

Identifiers

Primary DI / UDI-DI
06939716405257 EUDAMED
06971390434963 EUDAMED
06939716405264 EUDAMED
Basic UDI-DI
69713904309018H EUDAMED
Direct Marketing DI
06939716405257 EUDAMED
06971390434963 EUDAMED
06939716405264 EUDAMED
EMDN Code
W0102070102 FERRITIN EUDAMED

Classification

Device Class
Class B EUDAMED
Market of Registration
France EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Human Tissues

Yes

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™ Ferritin by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class B — 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 (3)

  • EUDAMED a1055061-9dc2-4b00-b2b5-8909017d3fee 61 fields · synced Jul 12, 2026
  • EUDAMED 7ba6177a-157b-4443-9c3c-476b50fd97d1 61 fields · synced May 17, 2026
  • EUDAMED 6392c6cc-b4c2-4bb5-81ea-7a36c3a0304e 61 fields · synced May 17, 2026