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Foam Ear Tips

by Natus Medical Denmark ApS 3 variants

Ref 80A4821100

Foam Ear Tips (80A4821100) is an audiometric ear tip (EU MDR Class I; FDA Class I; FDA product code ETT, Cushion, Earphone (For Audiometric Testing)) made by Natus Medical Denmark ApS, registered in EUDAMED on 14 Oct 2025 (Basic UDI-DI 5713315NA001075B) and listed in FDA GUDID since 31 Aug 2022 (UDI-DI 05713315009334), active (EUDAMED), not in commercial distribution (GUDID) as of 22 Oct 2026.

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

Source EUDAMED, GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number5713315NA001075B Basic UDI-DI 05713315009334UDI-DIDate14 Oct 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number05713315009334 UDI-DI Date31 Aug 2022ListedStatusListed GUDID: not in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 5713315NA001075B registered 14 Oct 2025 Active
  • FDA GUDID UDI-DI 05713315009334 listed 31 Aug 2022 Listed

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Timeline

2 dated events

  1. Listed FDA GUDID 05713315009334
  2. Registered EUDAMED 5713315NA001075B

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  • Withdrawn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
Foam Ear Tips EUDAMED
Foam Eartip 3C (Jumbo) GUDID
Generic name
Audiometric ear tip
Device name
Foam Eartip
Model / Ref / Catalog
80A4821100
Primary DI / UDI-DI
05713315009334
Basic UDI-DI
5713315NA001075B
FDA product code
ETT
EMDN code
Z121401 Audiometers
GMDN term
Audiometric ear tip
Device class
Class I
Regulation number
874.1100
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Denmark
GUDID distribution status
Not in Commercial Distribution

Manufacturer details

EUDAMED SRN
DK-MF-000001617

Similar devices in this category

Other devices filed under AUDIOMETERS.

Other devices from Natus Medical Denmark ApS

See all devices from Natus Medical Denmark ApS →

Properties

  • Single use
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (20, all answered No)