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Elite

by Medixdent International 1,000+ variants

Ref ED-175-052A

Active European Union

CE MDR

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None, self-declared

Class I: no certifier involved

Trust

Unverified

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

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number++G359CheekRetractors3S Basic UDI-DI +G359ED175052A02UDI-DIDate20 May 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

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

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Cheek Retractors
Model / Reference
ED-175-052A
Primary DI / UDI-DI
+G359ED175052A02
Basic UDI-DI
++G359CheekRetractors3S
EMDN Code
L150299 Odontostomatology spreaders and retractors, reusable - other
Device Class
Class I
EU market of registration
Belgium

Manufacturer details

EUDAMED SRN
PK-MF-000027173
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Medixdent International

See all devices from Medixdent International →

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