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Direct-R Gold

by Micro-Mega SA 17 variants

Ref 100092Model Direct-R Gold

Active European Union

CE MDD

Valid until

No date given

EUDAMED holds no validity date

FDA recalls

Not applicable

No FDA record for this device

Documents

None linked in EUDAMED

A group certificate may exist

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/MDD NumberB-03701310368916 Basic UDI-DI 03701310368916UDI-DIDate12 Oct 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDD Active

Specification

EUDAMED

Model / reference
Direct-R Gold, 100092
Primary DI / UDI-DI
03701310368916
Basic UDI-DI
B-03701310368916
EMDN code
Q010507 Endodontic instruments (canal enlargers, files, rasps, etc.), single-use
Device class
Class IIa
EU registration type
Legacy device (under a directive)
EU market of registration
France

Manufacturer details

EUDAMED SRN
FR-MF-000004141

Other devices from Micro Mega

See all devices from Micro Mega →

Properties

  • Supplied sterile
  • Sterilise before use

Other properties (12)

  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No