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LUNAR Universal Stain&Glaze, LUNAR PLUS Universal Stain&Glaze

by Medifive 35 variants

Ref Shade DModel LUNAR Universal Stain Shade A

Active European Union

CE MDR

Valid until

27 Aug 2030

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier BUREAU VERITAS ITALIA S.P.A.

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number88001361MF00043N Basic UDI-DI 08800136101204UDI-DIDate23 Dec 2025RegisteredStatusActive

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • IT345450 Active Supplemented

    Quality management system EU MDR

    Certifier
    BUREAU VERITAS ITALIA S.P.A. 1370
    Issued
    28 Nov 2025
    Expires
    27 Aug 2030
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
LUNAR Universal Stain Shade A, Shade D
Primary DI / UDI-DI
08800136101204
Basic UDI-DI
88001361MF00043N
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class IIa
EU market of registration
Spain

Manufacturer details

EUDAMED SRN
KR-MF-000016709
Authorised representative
AR Experts B.V. NL-AR-000023989

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Properties

Other properties (13)

  • 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