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Hokapi™ Testosterone

EUDAMED

Class B (EU MDR)

Ref 010404401Ref 010404601Ref 010404101Ref 010404001

by Suzhou Hokapi Biomedical Engineering Co., Ltd..

Identity

Trade Name
HOKAPI™ TESTOSTERONE EUDAMED
Device Name
HOKAPI™ TESTOSTERONE EUDAMED
Model / Reference
010404401 EUDAMED
010404601 EUDAMED
010404101 EUDAMED
010404001 EUDAMED

Identifiers

Primary DI / UDI-DI
06971390435335 EUDAMED
06939716404960 EUDAMED
06971390435342 EUDAMED
06939716404953 EUDAMED
Basic UDI-DI
69713904304047W EUDAMED
Direct Marketing DI
06971390435335 EUDAMED
06939716404960 EUDAMED
06971390435342 EUDAMED
06939716404953 EUDAMED
EMDN Code
W0102050110 TESTOSTERONE (WITH DEHYDRO AND FREE TESTOSTERONE) 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™ Testosterone 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 e738a5fa-ad3c-4e97-94be-77670b16542c 61 fields · synced Sep 17, 2026
  • EUDAMED 9e99d16a-82ea-4d79-9fc8-fdcc4e63a519 61 fields · synced May 16, 2026
  • EUDAMED d5334d9d-0949-4630-958c-342bfe0bf024 61 fields · synced May 18, 2026
  • EUDAMED f98463ed-670f-4171-a70e-6152055e8196 61 fields · synced May 19, 2026