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Parlez™ XL Electrolarynx

by Elogio Speech Technologies LLC

Ref PARLEZ XLModel Parlez Electrolarynx Family

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number00860012896875 UDI-DI Date9 Jun 2026ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number08600128968PARLEZEL55 Basic UDI-DI 00860012896875UDI-DIDate5 Jun 2026RegisteredStatusActive

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.

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  • Withdrawn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
Parlez™ XL Electrolarynx EUDAMED
Parlez Electrolarynx GUDID
Generic Name
Transcervical artificial larynx
Device Name
Electrolarynx (Artificial Larynx)
Model / Ref / Catalog
Parlez Electrolarynx Family, PARLEZ XL
Primary DI / UDI-DI
00860012896875
Basic UDI-DI
08600128968PARLEZEL55
FDA Product Code
ESE
EMDN Code
Y214299 Devices for interpersonal comunication - other
GMDN Term
Transcervical artificial larynx
Device Class
Class I
Regulation Number
874.3375
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution
MRI Safety
MR Unsafe

Manufacturer details

EUDAMED SRN
US-MF-000052790
Authorised representative
Europecert UG (haftungsbeschränkt) DE-AR-000004974

From the manufacturer

Manufacturer's product page: Parlez™ Electrolarynx

Other devices from Elogio Speech Technologies LLC

Properties

  • Over-the-Counter
  • Premarket Exempt
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Expiration Date: No