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The One that Controls

by Incidental Ltd

Ref INC-12Model Composite Instruments

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number50610785INC-10-328D Basic UDI-DI 05061075850094UDI-DIDate4 Sep 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  • Withdrawn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
Composite Instruments
Model / Reference
Composite Instruments, INC-12
Primary DI / UDI-DI
05061075850094
Basic UDI-DI
50610785INC-10-328D
EMDN Code
Q010199 Conservative dentistry and endodontics devices - other
Device Class
Class I
EU market of registration
France

Manufacturer details

EUDAMED SRN
UK-MF-000058209
Authorised representative
Advena SRL IT-AR-000051131

From the manufacturer

Manufacturer's product page: The One

Other devices from Incidental Ltd

See all devices from Incidental Ltd →

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