Skip to content

Impression Trays

by Hubei Guarddent Medical Technology Co., Ltd 6 variants

Ref Bite TrayModel Disposable(GD-1271 --GD-1296,GD-1331--GD-1340);Autoclavable(GD-1311--GD-1320);Implant Trays(GD-1321--GD-1330);Bite Tray(GD-1221--GD-1225,GD-1231--GD-1236,GD-1241--GD-1245);GD-1381--GD-1390

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 Number697565200IT001FD Basic UDI-DI Date26 Feb 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  • Withdrawn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
Disposable(GD-1271 --GD-1296,GD-1331--GD-1340);Autoclavable(GD-1311--GD-1320);Implant Trays(GD-1321--GD-1330);Bite Tray(GD-1221--GD-1225,GD-1231--GD-1236,GD-1241--GD-1245);GD-1381--GD-1390, Bite Tray
Primary DI / UDI-DI
06975652007582, 06975652007537, 06978502820751
Basic UDI-DI
697565200IT001FD
EMDN Code
Q010503 Impression material trays, single-use
Device Class
Class I
EU market of registration
Germany

Manufacturer details

EUDAMED SRN
CN-MF-000028116
Authorised representative
RIOMAVIX SOCIEDAD LIMITADA ES-AR-000001202

Other devices from Hubei Guarddent Medical Technology Co., Ltd

See all devices from Hubei Guarddent Medical Technology Co., Ltd →

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