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Soft Bitewing Flaps 656303

by Hager Worldwide, Inc.

Ref 656303Model Bite Wing Flap

Soft Bitewing Flaps 656303 is a Class I device made by Hager Worldwide, Inc., registered in EUDAMED on 5 Oct 2026 (Basic UDI-DI ++D248656303HWPE) and listed in FDA GUDID since 13 Jul 2023 (UDI-DI D2486563031), active as of 23 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D248656303HWPE Basic UDI-DI D2486563031UDI-DIDate5 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD2486563031 UDI-DI Date13 Jul 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI ++D248656303HWPE registered 5 Oct 2026 Active
  • FDA GUDID UDI-DI D2486563031 listed 13 Jul 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 D2486563031
  2. Registered EUDAMED ++D248656303HWPE

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  • Withdrawn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
Emmenix Flap EUDAMED
Soft Bitewing Flaps GUDID
Generic name
Dental x-ray film holder, single-use
Model / reference
656303, Bite Wing Flap
Primary DI / UDI-DI
D2486563031
Basic UDI-DI
++D248656303HWPE
Unit of use DI
D2486563030
FDA product code
EGZ
EMDN code
Z1399 Non-specific consumables for diagnostic instruments - other
GMDN term
Dental x-ray film holder, single-use
Device class
Class I
Regulation number
872.1905
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: Dental x-ray film holder, single-use

Similar devices in this category

Other devices filed under NON-SPECIFIC CONSUMABLES FOR DIAGNOSTIC INSTRUMENTS - 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)