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CompGloss RA - OccluStar

by Edenta Etablissement 2 variants

Ref 1141RA-6Model 16412

CompGloss RA - OccluStar (1141RA-6) is a Class IIa device made by Edenta Etablissement, registered in EUDAMED on 2 Feb 2022 (Basic UDI-DI ++E31216412DU) with CE/MDR certificate 1000183128 valid until 26 Mar 2030, active as of 24 Oct 2026.

Active European Union

CE MDR

Valid until

26 Mar 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier DQS Medizinprodukte GmbH

Trust

Unverified

Source EUDAMED, synced 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number1000183128 Date27 Mar 2025IssuedStatusActive expires 26 Mar 2030

Official records

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

Timeline

3 dated events

  1. Registered EUDAMED ++E31216412DU
  2. Certificate issued EUDAMED 1000183128
  3. Certificate expires EUDAMED 1000183128

Coverage

1 jurisdiction

SwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

European Union — CE/MDR Active

Specification

EUDAMED

Device name
Polierer / Arkansas
Model / reference
16412, 1141RA-6
Primary DI / UDI-DI
E3121141RA61
Basic UDI-DI
++E31216412DU
Unit of use DI
E3121141RA6101
EMDN code
Q01010403 Dental abrasive and polishing materials
Device class
Class IIa
EU registration type
Standard device
EU market of registration
Liechtenstein

Manufacturer details

EUDAMED SRN
LI-MF-000011937

Similar devices in this category

Other devices filed under DENTAL ABRASIVE AND POLISHING MATERIALS.

Other devices from Edenta Etablissement

See all devices from Edenta Etablissement →

Properties

  • Sterilise before use
Other properties (13, all answered No)