Live capture Wrist Watch Electronic Blood Pressure Monitor

EUDAMEDFDA 510(k)

Class IIa (EU MDR)

Ref U16PModel U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T

by Shenzhen Urion Technology Co., Ltd.

Identity

Trade Name: Live capture Wrist Watch Electronic Blood Pressure Monitor EUDAMED
Device Name: Wrist Watch Electronic Blood Pressure Monitor EUDAMED
Model / Reference: U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T EUDAMED
U16P EUDAMED

Identifiers

Primary DI / UDI-DI: 06953825911003 EUDAMED
Basic UDI-DI: 69538259UWPM67 EUDAMED
EMDN Code: Z1203020501 NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES EUDAMED

Classification

Device Class: Class IIa EUDAMED
Market of Registration: Italy EUDAMED

Clinical & Handling

Sterile

EUDAMED

Implantable

EUDAMED

Reusable

EUDAMED

Contains Latex

EUDAMED

Reprocessed

EUDAMED

CMR Substance

EUDAMED

Human-derived

EUDAMED

Human Tissues

EUDAMED

Animal Tissues

EUDAMED

Endocrine Disruptor

EUDAMED

Administering Medicine

EUDAMED

Measuring Function

Yes

EUDAMED

Incorporates Medicinal Product

EUDAMED

Live capture Wrist Watch Electronic Blood Pressure Monitor by Shenzhen Urion Technology Co., Ltd. — Class IIa — FDA_510K, MDR — listed in EUDAMED, FDA 510(k)

Authorization Coverage (2 countries)

Regulatory Authorizations

United States Active

FDA_510K

United States Active

FDA_510K

European Union Active

CE/MDR

Source	Region	Type	Cert / Approval No.	Class	Status
FDA 510(k)	United States	FDA_510K	K254048	Class IIa	Active
FDA 510(k)	United States	FDA_510K	K141683	Class IIa	Active
EUDAMED	European Union	CE/MDR	69538259UWPM67	Class IIa	Active

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer: Shenzhen Urion Technology Co., Ltd.
EUDAMED SRN: CN-MF-000018740
Authorised Representative: Wellkang Ltd XI-AR-000001836

Sources (2)

EUDAMED 387e1cad-951a-4e4c-a778-e688fec3f585 61 fields · synced Oct 6, 2026
FDA 510(k) K254048 1 fields · synced May 29, 2026