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Surgical Guide SG 2.0

by Shandong Huge Dental Material Corporation EUDAMEDGUDID

Active European Union

Ref SG 2.0/Clear/1.0 kg/bottleModel SG 2.0, SG 3.0, SG 4.0, SG Pro

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69094123DSGR101N3 Basic UDI-DIDate14 Sep 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06909412328044 UDI-DIDate19 May 2026ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 24 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Surgical Guide
Generic Name
Dental guided surgery reference plate
Model / Ref / Catalog
SG 2.0, SG 3.0, SG 4.0, SG Pro, SG 2.0/Clear/1.0 kg/bottle, Clear/1.0 kg/bottle
Primary DI / UDI-DI
06909412328044
Basic UDI-DI
69094123DSGR101N3
FDA Product Code
NDP
EMDN Code
Q010699 Materials for the preparation of custom-made dental devices - other
GMDN Term
Dental guided surgery reference plate
Device Class
Class I
Regulation Number
872.3980
Market of Registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SG 2.0, SG 3.0, SG 4.0, SG Pro
SG 2.0/Clear/1.0 kg/bottle
GUDID
SG 2.0

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Properties

  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No
  • Manufacturing Date: No