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Sdunw U80Z

by Shenzhen Urion Technology Co., Ltd

Ref 06953825910907Model U80Z

Sdunw U80Z is an automatic-inflation electronic sphygmomanometer (EU MDD Class IIa; FDA Class II; FDA product code DXN, System, Measurement, Blood-Pressure, Non-Invasive) made by Shenzhen Urion Technology Co., Ltd, registered in EUDAMED on 8 Jul 2026 (Basic UDI-DI B-06953825910907), cleared under FDA 510(k) K243115 on 21 Feb 2025 and listed in FDA GUDID since 16 Feb 2026 (UDI-DI 06953825910907), active as of 24 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDD 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 24 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K243115

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-06953825910907 Basic UDI-DI 06953825910907UDI-DIDate8 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06953825910907 UDI-DI Date16 Feb 2026ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK243115 Date21 Feb 2025DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI B-06953825910907 registered 8 Jul 2026 Active
  • FDA 510(k) K243115 decided 21 Feb 2025 Active
  • FDA GUDID UDI-DI 06953825910907 listed 16 Feb 2026 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K243115
  2. Listed FDA GUDID 06953825910907
  3. Registered EUDAMED B-06953825910907

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
Sdunw
Generic name
Automatic-inflation electronic sphygmomanometer, portable, arm/wrist
Device name
Upper Arm Electronic Blood Pressure Monitor
Model / reference
U80Z, 06953825910907
Primary DI / UDI-DI
06953825910907
Basic UDI-DI
B-06953825910907
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
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Legacy device (under a directive)
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Cleared under the same submission (K243115)

and 8 more cleared under K243115

Similar devices in this category

Other devices filed under NON–INVASIVE OSCILLOMETRIC BLOOD PRESSURE GAUGES.

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 (19, all answered No)