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SHINING 3D® Aoralscan Elf Pro

by Shining 3D Tech Co., Ltd.

Ref 8693Model Aoralscan Elf Pro

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

CE MDR

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number697016308AoralscanElfP7H Basic UDI-DI 06970163088693UDI-DIDate23 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06970163088693 UDI-DI Date21 Jul 2026ListedStatusListed 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  • Withdrawn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/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Aoralscan Elf Pro EUDAMED
Shining 3D® GUDID
Generic Name
Dental milling system, CAD/CAM, chairside
Model / Reference
Aoralscan Elf Pro, 8693
Primary DI / UDI-DI
06970163088693
Basic UDI-DI
697016308AoralscanElfP7H
Direct Marketing DI
06970163088693
FDA Product Code
NOF
EMDN Code
Q0199 Odontology devices - other
GMDN Term
Dental milling system, CAD/CAM, chairside
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
872.3661
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class I
GUDID
Class II

Other devices from Shining 3D Tech Co., Ltd.

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Properties

  • Premarket Exempt
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: 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
  • Lot / Batch Number: No