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Hokapi™ Prolactin

EUDAMED

Class B (EU MDR)

Ref 010403001Ref 010403601Ref 010403401Ref 010403101

by Suzhou Hokapi Biomedical Engineering Co., Ltd..

Identity

Trade Name
HOKAPI™ PROLACTIN EUDAMED
Device Name
HOKAPI™ PROLACTIN EUDAMED
Model / Reference
010403001 EUDAMED
010403601 EUDAMED
010403401 EUDAMED
010403101 EUDAMED

Identifiers

Primary DI / UDI-DI
06939716404939 EUDAMED
06939716404946 EUDAMED
06971390434932 EUDAMED
06971390434949 EUDAMED
Basic UDI-DI
69713904304037U EUDAMED
Direct Marketing DI
06939716404939 EUDAMED
06939716404946 EUDAMED
06971390434932 EUDAMED
06971390434949 EUDAMED
EMDN Code
W0102050108 PROLACTIN EUDAMED

Classification

Device Class
Class B 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™ Prolactin 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

Manufacturer
Suzhou Hokapi Biomedical Engineering Co., Ltd..
EUDAMED SRN
CN-MF-000013723
Authorised Representative
Shanghai International Holding Corp. GmbH(Europe) DE-AR-000000001

Sources (4)

  • EUDAMED f41daff1-35fd-4803-b3f0-cf43fcb9d10c 61 fields · synced Jul 29, 2026
  • EUDAMED b41bcf49-d3fc-4c44-81b1-e613e43775b3 61 fields · synced May 18, 2026
  • EUDAMED 4d0e84a3-47d8-40a8-8c97-474140d38e88 61 fields · synced May 18, 2026
  • EUDAMED be2a5490-aeeb-4432-b949-ef58d458c326 61 fields · synced May 18, 2026