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EV1000 Evhrs

by Edwards Lifesciences LLC

Ref EVHRS

EV1000 Evhrs is a device classified as Class IIb in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 1 Oct 2026 (Basic UDI-DI 0690103D001HNI000T4) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00690103193374), active as of 22 Oct 2026.

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

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001HNI000T4 Basic UDI-DI 00690103193374UDI-DIDate1 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00690103193374 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001HNI000T4 registered 1 Oct 2026 Active
  • FDA GUDID UDI-DI 00690103193374 listed 3 Sep 2016 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00690103193374
  2. Registered EUDAMED 0690103D001HNI000T4

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  • Withdrawn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
EV1000
Generic name
Patient positioning sensor
Device name
HemoSphere Non-Invasive
Model / Ref / Catalog
EVHRS
Primary DI / UDI-DI
00690103193374
Basic UDI-DI
0690103D001HNI000T4
FDA product code
DXN, DSB, DQK, QAQ, DXG
EMDN code
Z1203020280 Multi-parameter monitors - hardware accessories
GMDN term
Patient positioning sensor
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
870.1130, 870.2770, 870.1425, 870.2210, 870.1435
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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

Category: Patient positioning sensor

Similar devices in this category

Other devices filed under MULTI-PARAMETER MONITORS - HARDWARE ACCESSORIES.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Serial number
  • Expiration date
Other properties (22, all answered No)