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Insertion Test Device 02081

by Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

Ref 02081Model Ms0101ITD

Insertion Test Device 02081 is a device classified as Class IIa in the EU and Class III in the US made by Med-El Elektromedizinische Geräte Gesellschaft m.b.H., registered in EUDAMED on 1 Sep 2026 (Basic UDI-DI 9008737Ms0101ITD99), approved under FDA PMA P000025 on 20 Aug 2001 and listed in FDA GUDID since 22 Sep 2014 (UDI-DI 09008737020811), active as of 25 Oct 2026. One FDA recall is linked to it.

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

CE MDR PMA

Valid until

No date given

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

FDA recalls

1 ongoing

This device is named in the recall

Documents

None linked in EUDAMED

A group certificate may exist

PMA P000025

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number9008737Ms0101ITD99 Basic UDI-DI 09008737020811UDI-DIDate1 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number09008737020811 UDI-DI Date22 Sep 2014ListedStatusListed GUDID: in commercial distribution
United StatesFDA PMAAPPR GUDID from GUDID Approved NumberP000025 Date20 Aug 2001DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 9008737Ms0101ITD99 registered 1 Sep 2026 Active
  • FDA PMA P000025 decided 20 Aug 2001 Active
  • FDA GUDID UDI-DI 09008737020811 listed 22 Sep 2014 Listed

Recalls

4 recalls · 1 ongoing · FDA

    • Ongoing Z-2356-2024 FDA Class II initiated 18 Apr 2024

    A small number of devices may have a higher probability of a crack within the internal electronics substrate which could result in a non-functional device.

  • 3 recalls, same reason

    • Terminated Z-2138-2019 FDA Class II initiated 16 Oct 2018 on shared PMA P000025
    • Terminated Z-2136-2019 FDA Class II initiated 16 Oct 2018 on shared PMA P000025
    • Terminated Z-2137-2019 FDA Class II initiated 16 Oct 2018 on shared PMA P000025

    Devices were distributed despite the Helium-fine leak test results not being within the cochlear implant standards specification.

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Timeline

7 dated events

  1. Approved FDA PMA P000025
  2. Listed FDA GUDID 09008737020811
  3. Recall initiated FDA recalls Z-2138-2019
  4. Recall initiated FDA recalls Z-2136-2019
  5. Recall initiated FDA recalls Z-2137-2019
  6. Recall initiated FDA recalls Z-2356-2024
  7. Registered EUDAMED 9008737Ms0101ITD99

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA PMA Active

Specification

EUDAMED · GUDID

Trade name
Insertion Test Device
Generic name
Cochlear electrode array depth gauge, single-use
Model / reference
02081, Ms0101ITD
Primary DI / UDI-DI
09008737020811
Basic UDI-DI
9008737Ms0101ITD99
PMA number
FDA product code
MCM
EMDN code
Q030399 Instruments for ENT surgery, single-use - other
GMDN term
Cochlear electrode array depth gauge, single-use
Device class
Class IIa EUDAMED
Class III GUDID
EU registration type
Standard device
EU market of registration
Austria
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class III

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class III in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Cochlear electrode array depth gauge, single-use

Cleared under the same submission (P000025)

and 8 more cleared under P000025

Similar devices in this category

Other devices filed under INSTRUMENTS FOR ENT SURGERY, SINGLE-USE - OTHER.

Other devices from Med-El Elektromedizinische Geräte Gesellschaft m.b.H.

See all devices from Med-El Elektromedizinische Geräte Gesellschaft m.b.H. →

Properties

  • Supplied sterile
  • Single use
  • Prescription use
  • Serial number
  • Expiration date
  • Manufacturing date
Other properties (19, all answered No)