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Hertipro

EUDAMED

Class IIa (EU MDR)

Ref 06953825910440Model U80Y

by Shenzhen Urion Technology Co., Ltd.

Identity

Trade Name
HERTIPRO EUDAMED
Device Name
Upper Arm Electronic Blood Pressure Monitor EUDAMED
Model / Reference
U80Y EUDAMED
06953825910440 EUDAMED

Identifiers

Primary DI / UDI-DI
06953825910440 EUDAMED
Basic UDI-DI
B-06953825910440 EUDAMED
EMDN Code
Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED

Classification

Device Class
Class IIa EUDAMED
Market of Registration
Lithuania EUDAMED

Clinical & Handling

Sterile

No

EUDAMED

Implantable

No

EUDAMED

Reusable

No

EUDAMED

Contains Latex

No

EUDAMED

Reprocessed

No

EUDAMED

Human-derived

No

EUDAMED

Human Tissues

No

EUDAMED

Animal Tissues

No

EUDAMED

Administering Medicine

No

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

No

EUDAMED

Hertipro by Shenzhen Urion Technology Co., Ltd. — Class IIa — MDD — listed in EUDAMED — regulatory data on deviCERTS

Authorization Coverage (European Union — 27 member states)

Regulatory Authorizations

European Union Active

CE/MDD

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Manufacturer

EUDAMED SRN
CN-MF-000018740
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (1)

  • EUDAMED 84b49d28-7c55-474e-b93a-6831c4728b4e 61 fields · synced Jun 18, 2026