Skip to content

1077 Ear Coupler Cable 8-69-41200

by PATH medical GmbH

Ref 100127Model ECC

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0426022ECC-2a5Z Basic UDI-DI 04260223141386UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number04260223141386 UDI-DI Date29 Jun 2016ListedStatusListed GUDID: in commercial distribution

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  • Withdrawn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
Ecc-1 EUDAMED
1077 Ear Coupler Cable GUDID
Generic Name
Evoked-potential audiometer
Device Name
Ear Coupler Cable
Model / Reference
ECC EUDAMED
100127 EUDAMED
8-69-41200 GUDID
Primary DI / UDI-DI
04260223141386
Basic UDI-DI
0426022ECC-2a5Z
FDA Product Code
GWJ
EMDN Code
Z12140302 Evoked potential audiometry equipments
GMDN Term
Evoked-potential audiometer
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
882.1900
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
ECC
100127
GUDID
8-69-41200
Device ClassEUDAMED
Class IIa
GUDID
Class II

Other devices from PATH medical GmbH

See all devices from PATH medical GmbH →

Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (21)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No