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Bite Trays Quadrant (40 pcs) ‐ Unodent

by Young Innovations Inc

Ref 114142UNODENT

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, self-declared

Class I: no certifier involved

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 Number0843471116350D36733EHYDX Basic UDI-DI 10840326423346UDI-DIDate28 Jan 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number10840326423346 UDI-DI Date31 Jan 2025ListedStatusListed GUDID: in commercial distribution

Certificates

0 certificates · EUDAMED

No certifier certificate is listed. Devices of this class are self-declared by the manufacturer.

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  • Withdrawn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

Trade Name
Bite Trays Quadrant (40 pcs) ‐ Unodent EUDAMED
Astek GUDID
Generic Name
Dental impression tray, single-use
Device Name
Bite Trays
Model / Ref / Catalog
114142UNODENT
Primary DI / UDI-DI
10840326423346 EUDAMED
00840326423349 GUDID
Basic UDI-DI
0843471116350D36733EHYDX
FDA Product Code
EHY
EMDN Code
Q010503 Impression material trays, single-use
GMDN Term
Dental impression tray, single-use
Device Class
Class I
Regulation Number
872.6880
EU market of registration
Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Primary DI / UDI-DIEUDAMED
10840326423346
GUDID
00840326423349

Manufacturer details

EUDAMED SRN
US-MF-000017796
Authorised representative
MDSS GmbH DE-AR-000005430

Related devices

Category: Dental impression tray, single-use

Other devices from Young Innovations, Inc.

See all devices from Young Innovations, Inc. →

Properties

  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • 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
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No