Hokapi™ Tsh

EUDAMED

Class B (EU MDR)

Ref 010303401Model 50 TESTS

by Suzhou Hokapi Biomedical Engineering Co., Ltd..

Identity

Trade Name: HOKAPI™ TSH EUDAMED
Device Name: HOKAPI™ TSH EUDAMED
Model / Reference: 010303401 EUDAMED
50 TESTS EUDAMED

Identifiers

Primary DI / UDI-DI: 06971390434857 EUDAMED
Basic UDI-DI: 69713904303037P EUDAMED
B-06971390434857 EUDAMED
Direct Marketing DI: 06971390434857 EUDAMED
EMDN Code: W01020410 THYROID STIMULATING HORMONE EUDAMED

Classification

Device Class: Class B EUDAMED
Class IVD General EUDAMED
Market of Registration: France EUDAMED

Clinical & Handling

Sterile

EUDAMED

Human Tissues

Yes

EUDAMED

Animal Tissues

Yes

EUDAMED

Microbial Substances

EUDAMED

Reagent

Yes

EUDAMED

Self Testing

EUDAMED

Near-Patient Testing

EUDAMED

Professional Testing

Yes

EUDAMED

Companion Diagnostics

EUDAMED

Surgical Instrument

EUDAMED

New Device

EUDAMED

Hokapi™ Tsh by Suzhou Hokapi Biomedical Engineering Co., Ltd.. — Class B — IVDD, IVDR — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/IVDD

European Union Active

CE/IVDR

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	CE/IVDD	69713904303037P	Class B	Active
EUDAMED	European Union	CE/IVDR	69713904303037P	Class B	Active

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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 (2)

EUDAMED f7ee5054-57b4-41f9-95d9-796a8208a689 61 fields · synced Jul 24, 2026
EUDAMED eb9ac248-a6a6-4770-b058-dd1e639edfc1 61 fields · synced May 17, 2026