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Echo SCreen III Accessories

by Natus Medical Denmark ApS 4 variants

Ref 010999Model 011010

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

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

None found

in data synced 22 Oct 2026

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
European UnionCE/MDR EUDAMED Number5713315NA001415B Basic UDI-DI 05713315012037UDI-DIDate28 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05713315012037 UDI-DI Date28 Jan 2026ListedStatusListed 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.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

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  • Withdrawn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
Echo SCreen III Accessories EUDAMED
Echo-Screen III GUDID
Generic Name
Evoked-potential audiometer
Device Name
Echo-Screen III Docking Station
Model / Ref / Catalog
011010, 010999
Primary DI / UDI-DI
05713315012037
Basic UDI-DI
5713315NA001415B
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

  • Reusable
  • Prescription Use
  • Lot / Batch Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: 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
  • Serial Number: No
  • Expiration Date: No