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En

by Aidite（Qinhuangdao）Technology Co., Ltd. EUDAMED

Active European Union

Ref 92×75×20-MultilayerModel 95×20-Multilayer

Regulatory status

as of 27 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD Number697645949RMM2B Basic UDI-DIDate28 May 2026RegisteredStatusActive
European UnionCE/MDR Number697645949RMM2B Basic UDI-DIDate28 May 2026RegisteredStatusActive

Coverage

1 jurisdiction

SwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

European Union — CE/MDD, CE/MDR Active

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.

Specification

EUDAMED

Trade Name
En
PMMA blocks for dental use
Model / Reference
95×20-Multilayer, 92×75×20-Multilayer
Primary DI / UDI-DI
06934906688564, 06934906688526, 06934906688540, 06934906688571, 06934906688557, 06934906688533, 06934906688502, 06934906688496, 06934906688489
Basic UDI-DI
697645949RMM2B, B-06934906688526, B-06934906688540, B-06934906688571, B-06934906688557, B-06934906688533, B-06934906688502, B-06934906688496, B-06934906688564, B-06934906688489
EMDN Code
Q01010101, Q01010199
Device Class
Class IIa
Market of Registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000015573
Authorised representative
AIDITE Europe GmbH DE-AR-000048785

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Properties

  • Reusable YesEUDAMEDNoEUDAMED

Other properties (12)

  • Sterile: No
  • Implantable: 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