Skip to content

Dental Model M 2.0

by Shandong Huge Dental Material Corporation EUDAMEDGUDID

Active European Union

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

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number69094123DM101FY Basic UDI-DIDate9 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number06909412319455 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  • Withdrawn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 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Dental Model
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 2.0/1.0 kg/bottle, 1.0 kg/bottle
Primary DI / UDI-DI
06909412319455
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
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 2.0/1.0 kg/bottle
GUDID
M 2.0

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