Skip to content

3 pcs Pack (Universal St, Basic)

by Yamakin Co., Ltd.

Ref A・UNOModel Dental Resin

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 linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR Number456023117D10B104N001VH Basic UDI-DI 04580797161024UDI-DIDate7 Mar 2024RegisteredStatusActive

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  • Withdrawn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/MDR Active

Specification

EUDAMED

Device Name
A・uno
Model / Reference
Dental Resin, A・UNO
Primary DI / UDI-DI
04580797161024
Basic UDI-DI
456023117D10B104N001VH
EMDN Code
Q01010103 Dental restorative composites
Device Class
Class IIa
EU market of registration
Italy

Manufacturer details

EUDAMED SRN
JP-MF-000011382
Authorised representative
Medical Technology Promedt Consulting GmbH DE-AR-000000085

Other devices from Yamakin Co., Ltd.

See all devices from Yamakin Co., 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