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Elastomeric Impression Material

by Shandong Huge Dental Material Corporation 27 variants

Ref Type 2 (Regular Body Dispenser-Mix Normal Set)/50ml/bio-cartridge, 2 bio-cartridges/box+6 Mixers/MonophaseModel Type 0; Type 1; Type 2; Type 3

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 Number6909412GXJ101VW Basic UDI-DI 06909412320604UDI-DIDate28 Jul 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  • Withdrawn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
Type 0, Type 1, Type 2, Type 3, Type 2 (Regular Body Dispenser-Mix Normal Set)/50ml/bio-cartridge, 2 bio-cartridges/box+6 Mixers/Monophase
Primary DI / UDI-DI
06909412320604
Basic UDI-DI
6909412GXJ101VW
EMDN Code
Q01020104 Dental impression silicones
Device Class
Class I
EU market of registration
Germany

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

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