Skip to content

Almore Bite Registration Tabs 42602

by Hager Worldwide, Inc.

Ref 42602Model Bite Wax

Almore Bite Registration Tabs 42602 is a Class I device made by Hager Worldwide, Inc., registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI ++D248WaxYB) and listed in FDA GUDID since 12 Sep 2023 (UDI-DI D248426021), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D248WaxYB Basic UDI-DI D248426021UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD248426021 UDI-DI Date12 Sep 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++D248WaxYB registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI D248426021 listed 12 Sep 2023 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 D248426021
  2. Registered EUDAMED ++D248WaxYB

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  • Withdrawn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
Almore Bite Registration Wax Tabs EUDAMED
Almore Bite Registration Tabs GUDID
Generic name
Bite registration rim wax
Device name
Almore Bit Registration Wax Sheet
Model / reference
42602, Bite Wax
Primary DI / UDI-DI
D248426021
Basic UDI-DI
++D248WaxYB
Unit of use DI
D248426020
FDA product code
EGD
EMDN code
Q01020199 Dental impression materials - other
GMDN term
Bite registration rim wax
Device class
Class I
Regulation number
872.6890
System or procedure pack
Procedure pack which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Related devices

Category: Bite registration rim wax

Similar devices in this category

Other devices filed under DENTAL IMPRESSION MATERIALS - OTHER.

Other devices from Hager Worldwide, Inc.

See all devices from Hager Worldwide, Inc. →

Properties

  • Single use
  • Premarket exempt
  • Lot / batch number
Other properties (22, all answered No)