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EV1000 EVEC1

by Edwards Lifesciences LLC

Part of a family of 15 devices: see the family page

Ref EVEC1

EV1000 EVEC1 is a device classified as Class I in the EU and Class II in the US made by Edwards Lifesciences LLC, registered in EUDAMED on 3 Oct 2026 (Basic UDI-DI 0690103D001EVA000SV), cleared under FDA 510(k) K160552 on 1 Jun 2016 (1 earlier submission) and listed in FDA GUDID since 3 Sep 2016 (UDI-DI 00690103190137), active as of 22 Oct 2026. One FDA recall is linked to it.

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

CE MDR 510(k)

Valid until

No date given

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

FDA recalls

None ongoing

1 closed

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K160552

+1 more

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0690103D001EVA000SV Basic UDI-DI 00690103190137UDI-DIDate3 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00690103190137 UDI-DI Date3 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK160552 Date1 Jun 2016DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 0690103D001EVA000SV registered 3 Oct 2026 Active
  • FDA 510(k) K160552 decided 1 Jun 2016 Active· +1 more in the status table
  • FDA GUDID UDI-DI 00690103190137 listed 3 Sep 2016 Listed

Recalls

1 recall · FDA

    • Terminated Z-1193-2019 FDA Class I initiated 21 Mar 2019

    Potential for an electrical short circuit leading to possible fire hazard due to liquid ingress into AC power outlets.

Timeline

5 dated events

  1. Cleared FDA 510(k) K131892
  2. Cleared FDA 510(k) K160552
  3. Listed FDA GUDID 00690103190137
  4. Recall initiated FDA recalls Z-1193-2019
  5. Registered EUDAMED 0690103D001EVA000SV

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · GUDID

Trade name
EV1000
Generic name
Electrical-only medical device connection cable, reusable
Device name
EV1000 Accessories
Model / Ref / Catalog
EVEC1
Primary DI / UDI-DI
00690103190137
Basic UDI-DI
0690103D001EVA000SV
510(k) Number
FDA product code
DXG, DSB, DXN
EMDN code
Z12030299 Vital signs monitoring instruments - other
GMDN term
Electrical-only medical device connection cable, reusable
Device class
Class I EUDAMED
Class II GUDID
Regulation number
870.1435, 870.2770, 870.1130
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution
Size
Length — 6 Feet

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class I
GUDID
Class II

Device class is stated on each registry's own scale: Class I 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: Electrical-only medical device connection cable, reusable

Cleared under the same submission (K131892)

and 8 more cleared under K131892

Cleared under the same submission (K160552)

and 8 more cleared under K160552

Similar devices in this category

Other devices filed under VITAL SIGNS MONITORING INSTRUMENTS - OTHER.

Other devices from Edwards Lifesciences LLC

See all devices from Edwards Lifesciences LLC →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (22, all answered No)