Skip to content

Algo 3i

by Natus Medical Denmark ApS 5 variants

Ref 010726

Algo 3i (010726) is a device classified as Class I in the EU and Class II in the US made by Natus Medical Denmark ApS, registered in EUDAMED on 12 Dec 2025 (Basic UDI-DI 5713315NA001425D), cleared under FDA 510(k) K030823 on 9 Apr 2003 and listed in FDA GUDID since 17 Dec 2025 (UDI-DI 05713315012235), active as of 22 Oct 2026.

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) K030823

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number05713315012235 UDI-DI Date17 Dec 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5713315NA001425D Basic UDI-DI 05713315012235UDI-DIDate12 Dec 2025RegisteredStatusActive
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Special NumberK030823 Date9 Apr 2003DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 5713315NA001425D registered 12 Dec 2025 Active
  • FDA 510(k) K030823 decided 9 Apr 2003 Active
  • FDA GUDID UDI-DI 05713315012235 listed 17 Dec 2025 Listed

Recalls

1 recall · FDA

    • Terminated Z-0985-05 FDA Unclassified (pre-2012) initiated 27 Jun 2005 on shared 510(k) K030823

    Internal investigation revealed that Preamp cable assemblies in the device had not been properly tested, which could lead to potential shock to users.

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

Timeline

4 dated events

  1. Cleared FDA 510(k) K030823
  2. Recall initiated FDA recalls Z-0985-05
  3. Registered EUDAMED 5713315NA001425D
  4. Listed FDA GUDID 05713315012235

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  • Withdrawn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

Generic name
Evoked-potential audiometer
Device name
ATA 3i Cable Assembly, V.2, CI
Model / Ref / Catalog
010726
Primary DI / UDI-DI
05713315012235
Basic UDI-DI
5713315NA001425D
510(k) Number
FDA product code
GWJ
EMDN code
Z129013 General auditory and/or visual stimulators
GMDN term
Evoked-potential audiometer
Device class
Class I EUDAMED
Class II GUDID
Regulation number
882.1900
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
In Commercial Distribution
MRI safety
MR Unsafe

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.

Manufacturer details

EUDAMED SRN
DK-MF-000001617

Related devices

Category: Auditory stimulator

Similar devices in this category

Other devices filed under VARIOUS INSTRUMENTS FOR FUNCTIONAL EXPLORATION AND THERAPEUTIC INTERVENTIONS.

Other devices from Natus Medical Denmark ApS

See all devices from Natus Medical Denmark ApS →

Properties

  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (22, all answered No)