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Prophylaxe Bürste SC rosa

by Edenta Etablissement 2 variants

Ref 1482SC-100Model 16412

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

CE MDR

Valid until

26 Mar 2030

CE MDR certificate

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

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 Number1000183128 Date27 Mar 2025IssuedStatusActive expires 26 Mar 2030
United StatesGUDID listing GUDID NumberE3121482SC1001 UDI-DI Date3 Feb 2022ListedStatusListed GUDID: in commercial distribution

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • 1000183128 Active

    Quality management system EU MDR

    Certifier
    DQS Medizinprodukte GmbH 0297
    Issued
    27 Mar 2025
    Expires
    26 Mar 2030

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  • Withdrawn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
Prophylaxe Bürste SC rosa EUDAMED
Edenta GUDID
Generic Name
Dental-professional prophylaxis brush, single-use
Device Name
Polierer / Arkansas
Model / Reference
16412, 1482SC-100
Primary DI / UDI-DI
E3121482SC1001
Basic UDI-DI
++E31216412DU
Unit of Use DI
E3121482SC100101
FDA Product Code
EJQ
EMDN Code
Q01010403 Dental abrasive and polishing materials
GMDN Term
Dental-professional prophylaxis brush, single-use
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
872.6010
EU market of registration
Liechtenstein
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
LI-MF-000011937

Other devices from Edenta Etablissement

See all devices from Edenta Etablissement →

Properties

  • Premarket Exempt
  • Lot / Batch Number
  • Manufacturing Date

Other properties (21)

  • Sterile: No
  • Single Use: 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Expiration Date: No