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Cerumen Hook

by Adept Medical Ltd

Ref NZ3441-100

Cerumen Hook (NZ3441-100) is a Class I device made by Adept Medical Ltd, registered in EUDAMED on 21 Jul 2022 (Basic UDI-DI 942190197047NZ3441-100UJ) and listed in FDA GUDID since 23 Apr 2024 (UDI-DI 09421901970475), active as of 22 Oct 2026.

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

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
United StatesGUDID listing GUDID Number09421901970475 UDI-DI Date23 Apr 2024ListedStatusListed GUDID: in commercial distribution
European UnionCE/MDR EUDAMED Number942190197047NZ3441-100UJ Basic UDI-DI 09421901970475UDI-DIDate21 Jul 2022RegisteredStatusActive

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 942190197047NZ3441-100UJ registered 21 Jul 2022 Active
  • FDA GUDID UDI-DI 09421901970475 listed 23 Apr 2024 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. Registered EUDAMED 942190197047NZ3441-100UJ
  2. Listed FDA GUDID 09421901970475

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  • Withdrawn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
Endaural surgical curette, single-use
Model / reference
NZ3441-100
Primary DI / UDI-DI
09421901970475
Basic UDI-DI
942190197047NZ3441-100UJ
FDA product code
JYG
EMDN code
Q0399 ENT devices - other
GMDN term
Endaural surgical curette, single-use
Device class
Class I
Regulation number
874.4420
EU registration type
Standard device
EU market of registration
Estonia
GUDID distribution status
In Commercial Distribution

Manufacturer details

EUDAMED SRN
NZ-MF-000003374
Authorised representative
Qualrep Services B.V. NL-AR-000000537

Similar devices in this category

Other devices filed under ENT DEVICES - OTHER.

Other devices from Adept Medical Ltd

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Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (21, all answered No)