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Mini FlexiBuff

by Cosmedent, Inc. 3 variants

Ref 402658

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

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++D779DISCBUFF101BV Basic UDI-DI D7794026580UDI-DIDate22 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberD7794026580 UDI-DI Date22 Jan 2020ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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
FlexiBuff Mini 5/8
Generic Name
Dental abrasive disk, single-use
Device Name
Mini FlexiBuff
Model / Reference
402658
Primary DI / UDI-DI
D7794026580 EUDAMED
D7734026581 GUDID
Basic UDI-DI
++D779DISCBUFF101BV
FDA Product Code
EHJ
EMDN Code
Q01010403 Dental abrasive and polishing materials
GMDN Term
Dental abrasive disk, single-use
Device Class
Class I
Regulation Number
872.6010
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
D7794026580
GUDID
D7734026581

Manufacturer details

EUDAMED SRN
US-MF-000045496
Authorised representative
SAS Exclusivas Dentales S.L. ES-AR-000045423

Other devices from Cosmedent, Inc.

See all devices from Cosmedent, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt

Other properties (21)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No