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Dental Model

by Shandong Huge Dental Material Corporation

Ref M 3.0/1.0 kg/bottleModel M 2.0, M 3.0, H 2.0, D 2.0, L 2.0

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69094123DM101FY Basic UDI-DI 06909412327825UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06909412327825 UDI-DI Date19 May 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  • Withdrawn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

Generic Name
Dental impression tray, single-use
Model / Ref / Catalog
M 2.0, M 3.0, H 2.0, D 2.0, L 2.0, M 3.0/1.0 kg/bottle, 1.0 kg/bottle
Primary DI / UDI-DI
06909412327825
Basic UDI-DI
69094123DM101FY
FDA Product Code
EBH
EMDN Code
Q0102050199 Dentistry resins - other
GMDN Term
Dental impression tray, single-use
Device Class
Class I
Regulation Number
872.3670
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
M 2.0, M 3.0, H 2.0, D 2.0, L 2.0
M 3.0/1.0 kg/bottle
GUDID
M 3.0

Manufacturer details

EUDAMED SRN
CN-MF-000013266
Authorised representative
MedNet EC-REP GmbH DE-AR-000000002

Other devices from Shandong Huge Dental Material Corporation

See all devices from Shandong Huge Dental Material Corporation →

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