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Wbp-02a

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref N/AModel WBP-02A510(k) K251581

by Shenzhen Hingmed Medical Instrument Co., Ltd.

Identity

Trade Name
WBP-02A EUDAMED
Device Name
Wearable Ambulatory Blood Pressure Monitor EUDAMED
Model / Reference
WBP-02A EUDAMED
N/A EUDAMED

Identifiers

Primary DI / UDI-DI
D-06975164324436UF EUDAMED
Basic UDI-DI
B-06975164324436UF EUDAMED
510(k) Number
K251581 FDA 510(k)
FDA Product Code
DXN FDA 510(k)
EMDN Code
Z1203020302 NON–INVASIVE BLOOD PRESSURE MONITORING INSTRUMENTS EUDAMED

Classification

Device Class
Class IIa EUDAMED
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 870.1130 FDA 510(k)
Regulation Number
870.1130 FDA 510(k)
Market of Registration
Italy EUDAMED
Advisory Committee
Cardiovascular FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

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

Wbp-02a by Shenzhen Hingmed Medical Instrument Co., Ltd. — Class IIa — MDR, FDA_510K, MDD — listed in EUDAMED, FDA 510(k) — regulatory data on deviCERTS

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

CE/MDR

United States Active

FDA_510K

European Union Active

CE/MDD

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Manufacturer

Manufacturer
Shenzhen Hingmed Medical Instrument Co., Ltd.
EUDAMED SRN
CN-MF-000004838
Authorised Representative
Wellkang Ltd XI-AR-000001836

Sources (3)

  • EUDAMED 901e15e7-4dda-4cc3-95a1-67d1361f5804 61 fields · synced Jul 26, 2026
  • FDA 510(k) K251581 24 fields · synced May 18, 2026
  • EUDAMED 13e9e77e-7dca-4537-8d4f-2fa6794855e6 61 fields · synced Jul 26, 2026