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Algo 3i

by Natus Medical Denmark ApS 5 variants

Ref 030697Model 010726

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None ongoing

1 closed

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 Number05713315011726 UDI-DI Date17 Dec 2025ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number5713315NA001425D Basic UDI-DI 05713315011726UDI-DIDate12 Dec 2025RegisteredStatusActive

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

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.

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  • Withdrawn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

Generic Name
Evoked-potential audiometer
Device Name
ATA 3i Cable Assembly, V.2, CI
Model / Ref / Catalog
010726, 030697
Primary DI / UDI-DI
05713315011726
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
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

Manufacturer details

EUDAMED SRN
DK-MF-000001617

Other devices from Natus Medical Denmark ApS

See all devices from Natus Medical Denmark ApS →

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