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Fx Anterior/Fx Posterior 4 Plate Sample

by Yamahachi Dental Mfg., Co. 258 variants

Ref 28*1SETS,S4LA4M30,UL,A3.5

Active European Union

CE MDR

Valid until

12 Jun 2031

CE MDR certificate

FDA recalls

Not applicable

No FDA record for this device

Documents

1 certificate

Certifier SGS Belgium NV

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 NumberJP26/00000198 Date31 Jul 2026IssuedStatusActive expires 12 Jun 2031

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • JP26/00000198 Active Amended

    Quality management system EU MDR

    Certifier
    SGS Belgium NV 1639
    Issued
    31 Jul 2026
    Expires
    12 Jun 2031
    Reason
    Other

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Device Name
Acrylic resin teeth (FX)
Model / Reference
28*1SETS, S4LA4M30, UL, A3.5
Primary DI / UDI-DI
D0804SFAPZ113ULA350
Basic UDI-DI
++D08038643FX9NN
EMDN Code
Q01020601 Mobile dental prostheses
Device Class
Class IIa
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
JP-MF-000024849
Authorised representative
Obelis s.a. BE-AR-000000106

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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