Skip to content

Aidite Multilayer-3D

by Aidite (Qinhuangdao) Technology Co., Ltd. 2 variants

Ref 95×14-Multilayer-3DModel 65×25×22-Multilayer-3D

Active European Union. Also listed in GUDID (US).

CE MDR CE MDD

Valid until

Not listed

EUDAMED holds no validity date

FDA recalls

Not checked

No FDA submission to match recalls against

Documents

None linked in EUDAMED

A group certificate may exist

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED Number697844793ZCM35 Basic UDI-DI 06976459490331UDI-DIDate28 May 2026RegisteredStatusActive
European UnionCE/MDR EUDAMED Number697844793ZCM35 Basic UDI-DI 06976459490331UDI-DIDate28 May 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06976459490331 UDI-DI Date14 Oct 2023ListedStatusListed GUDID: in commercial distribution

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

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDD, CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
En EUDAMED
Dental Zirconia Ceramic EUDAMED
Aidite GUDID
Generic Name
Dental appliance fabrication material, ceramic
Model / Reference
65×25×22-Multilayer-3D EUDAMED
95×14-Multilayer-3D EUDAMED
Multilayer-3D GUDID
Primary DI / UDI-DI
06976459490331
Basic UDI-DI
697844793ZCM35, B-06976459490331
FDA Product Code
EIH
EMDN Code
Q01010101, Q01010199
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
65×25×22-Multilayer-3D
95×14-Multilayer-3D
GUDID
Multilayer-3D
Device ClassEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from Aidite (Qinhuangdao) Technology Co., Ltd.

See all devices from Aidite (Qinhuangdao) Technology Co., Ltd. →

Properties

  • Single Use
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (19)

  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No