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Disposable Laryngeal Electrodes

by Suzhou Haishen Medical Device Associates Co., Ltd. 4 variants

Ref LAE-4/32×37, LAE-4/32×29

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

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) K232888↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697371968DLE004LS Basic UDI-DI Date17 Apr 2025RegisteredStatusActive
United StatesFDA 510(k) 510(k) NumberK232888 Date21 Dec 2023IssuedStatusActive

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 24 Oct 2026.

Coverage

2 jurisdictions

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  • Withdrawn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

Specification

EUDAMED · 510(k)

Model / Reference
LAE-4/32×37, LAE-4/32×29
Primary DI / UDI-DI
16973719680119, 16973719680102, 16973719688085
Basic UDI-DI
697371968DLE004LS, 697371968DLE003LQ
EMDN Code
N010101 Electromyographic electrodes
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000034513
Authorised representative
MedPath GmbH DE-AR-000000087

Other devices from Suzhou Haishen United Medical Device Associates Co., Ltd.

See all devices from Suzhou Haishen United Medical Device Associates Co., Ltd. →

Properties

Other properties (13)

  • Sterile: 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No