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Wrist Watch Electronic Blood Pressure Monitor

by Shenzhen Urion Technology Co., Ltd.

Ref U19MModel U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T

Active European Union. Also listed in GUDID (US).

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06953825911331 UDI-DI Date12 Aug 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69538259UWPM67 Basic UDI-DI Date23 Dec 2025RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 25 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Wrist Watch Electronic Blood Pressure Monitor
Alphamed Wrist Watch Electronic Blood Pressure Monitor
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Model / Reference
U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T
Primary DI / UDI-DI
06953825911331 EUDAMED
06953825911409 EUDAMED
06953825911591 EUDAMED
06953825911782 GUDID
Basic UDI-DI
69538259UWPM67
510(k) Number
FDA Product Code
DXN
EMDN Code
Z1203020501 Non–invasive oscillometric blood pressure gauges
GMDN Term
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
870.1130
EU market of registration
Ireland
Northern Ireland
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06953825911331
06953825911409
06953825911591
GUDID
06953825911782
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

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

Other devices from Shenzhen Urion Technology Co., Ltd

See all devices from Shenzhen Urion Technology Co., Ltd →

Properties

  • Measuring Function
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No