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Celtra® CELTRA Duo HT B1, C14, 4ST

by DeguDent GmbH

Ref 5365411255

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++EDD1HSGCERAMICSFJ Basic UDI-DI EDD153654112550UDI-DIDate6 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID NumberEDD153654112550 UDI-DI Date12 Nov 2024ListedStatusListed 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  • Withdrawn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

Trade Name
CELTRA Duo HT B1, C14, 4PCS EUDAMED
Celtra® GUDID
Generic Name
Dental appliance fabrication material, ceramic
Device Name
Basic UDI High Strength Glass
Model / Ref / Catalog
5365411255, CELTRA Duo HT B1, C14, 4ST
Primary DI / UDI-DI
EDD153654112550
Basic UDI-DI
++EDD1HSGCERAMICSFJ
FDA Product Code
EIH
EMDN Code
Q010299 Prosthetic dentistry devices - other
GMDN Term
Dental appliance fabrication material, ceramic
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.6660
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
5365411255
GUDID
CELTRA Duo HT B1, C14, 4ST
Device ClassEUDAMED
Class IIa
GUDID
Class II
ImplantableEUDAMED
Yes
GUDID
No

Related devices

Category: Dental appliance fabrication material, ceramic

Other devices from DeguDent GmbH

See all devices from DeguDent GmbH →

Properties

  • Single Use
  • Implantable YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (18)

  • Sterile: 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
  • Premarket Exempt: No
  • Serial Number: No