Skip to content

Alphamed Wrist Watch Electronic Blood Pressure Monitor

by Shenzhen Urion Technology Co., Ltd.

Ref U19SModel 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 2 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 2 Nov 2026. What this means

Regulatory status

as of registry sync 2 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06953825911614 UDI-DI Date14 Oct 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number69538259UWPM67 Basic UDI-DI 06953825911614UDI-DIDate23 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 2 Nov 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  • Withdrawn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
Alphamed Wrist Watch Electronic Blood Pressure Monitor EUDAMED
saidian GUDID
Generic Name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Device Name
Wrist Watch Electronic Blood Pressure Monitor
Model / Reference
U16H, U16L, U16P, U16W, U19M, U19R, U19S, and U19T
Primary DI / UDI-DI
06953825911614 EUDAMED
06953825911904 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
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
06953825911614
GUDID
06953825911904
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
  • Over-the-Counter
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • 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
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No