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DIAFIL Refill A3O

by DiaDent Group International

Ref A2001-1213Model DIAFIL Refill Package A3O

DIAFIL Refill A3O (A2001-1213) is a device classified as Class IIa in the EU and Class II in the US made by DiaDent Group International, registered in EUDAMED on 29 May 2026 (Basic UDI-DI B-08806383565035) and listed in FDA GUDID since 23 Apr 2020 (UDI-DI 08806383565035), active as of 23 Oct 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 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806383565035 Basic UDI-DI 08806383565035UDI-DIDate29 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383565035 UDI-DI Date23 Apr 2020ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-08806383565035 registered 29 May 2026 Active
  • FDA GUDID UDI-DI 08806383565035 listed 23 Apr 2020 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08806383565035
  2. Registered EUDAMED B-08806383565035

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  • Withdrawn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
Diafil
Generic name
Dental composite resin
Model / Ref / Catalog
DIAFIL Refill Package A3O, A2001-1213, Refill A3O
Primary DI / UDI-DI
08806383565035
Basic UDI-DI
B-08806383565035
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
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
DIAFIL Refill Package A3O
A2001-1213
GUDID
Refill A3O
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 DiaDent Group International

See all devices from DiaDent Group International →

Properties

  • Implantable YesEUDAMEDNoGUDID
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (19, all answered No)