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DiaFil Flow Intro Kit A3.5

by DiaDent Group International

Ref A2001-4306Model DIAFIL FLOW Intro Kit A3.5

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

CE MDD

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08806383576321 Basic UDI-DI 08806383576321UDI-DIDate8 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08806383576321 UDI-DI Date27 Apr 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

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  • Withdrawn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 Flow
Generic Name
Dental composite resin
Model / Ref / Catalog
DIAFIL FLOW Intro Kit A3.5, A2001-4306, Intro Kit A3.5
Primary DI / UDI-DI
08806383576321
Basic UDI-DI
B-08806383576321
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 market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DIAFIL FLOW Intro Kit A3.5
A2001-4306
GUDID
Intro Kit A3.5
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Dental composite resin

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 (18)

  • Sterile: No
  • Single Use: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No