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Rodin Surgical Guide

by The Belport Company, Inc. DBA Gingi-Pak

Ref 23687

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, self-declared

Class I: no certifier involved

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 Number081874602630300GR Basic UDI-DI 00818746023494UDI-DIDate24 Aug 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

Coverage

1 jurisdiction

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  • Withdrawn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

European Union — CE/MDR Active

Specification

EUDAMED

Model / Reference
23687
Primary DI / UDI-DI
00818746023494
Basic UDI-DI
081874602630300GR
Direct Marketing DI
00818746023494
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
Device Class
Class I
EU market of registration
Austria

Manufacturer details

EUDAMED SRN
US-MF-000044279
Authorised representative
Llins Service & Consulting GmbH DE-AR-000009077

From the manufacturer

Manufacturer's product page: Rodin® Surgical Guide$255.23

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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