Skip to content

Ezfil B4 9424

by Meta Biomed Co., Ltd.

Model Ezfil B4

Ezfil B4 9424 is a device classified as Class IIa in the EU and Class II in the US made by Meta Biomed Co., Ltd., registered in EUDAMED on 8 Jun 2026 (Basic UDI-DI B-08806387894247) and listed in FDA GUDID since 15 Mar 2020 (UDI-DI 08806387894247), active as of 12 Nov 2026.

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

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Source EUDAMED, GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806387894247 Basic UDI-DI 08806387894247UDI-DIDate8 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806387894247 UDI-DI Date15 Mar 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806387894247 registered 8 Jun 2026 Active
  • FDA GUDID UDI-DI 08806387894247 listed 15 Mar 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806387894247
  2. Registered EUDAMED B-08806387894247

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade name
Ezfil EUDAMED
Ezfil B4 GUDID
Generic name
Dental composite resin
Model / reference
Ezfil B4 EUDAMED
9424 GUDID
Primary DI / UDI-DI
08806387894247
Basic UDI-DI
B-08806387894247
FDA product code
EBF
EMDN code
Q01010103 Dental restorative composites
GMDN term
Dental composite resin
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
872.3690
EU registration type
Legacy device (under a directive)
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
Ezfil B4
GUDID
9424
Device classEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Dental composite resin

Similar devices in this category

Other devices filed under DENTAL RESTORATIVE COMPOSITES.

Other devices from Meta Biomed Co., Ltd.

See all devices from Meta Biomed Co., Ltd. →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (18, all answered No)