Skip to content

VSXE One Intro pack

by Kettenbach GmbH & Co. KG Germany EUDAMEDGUDID

Ref 14732Model Identium

Product code ELWEMDN Q01020103

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID NumberE217147321 UDI-DIDate30 May 2023ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number++E217IMPIDENTIUMFJ Basic UDI-DIDate19 Nov 2021RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 22 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 22 Oct 2026

Trade Name
VSXE One Intro pack EUDAMED
VSXE One GUDID
Generic Name
Silicone dental impression material
Device Name
Identium
Model / Ref / Catalog
Identium, 14732
Primary DI / UDI-DI
E217147321
Basic UDI-DI
++E217IMPIDENTIUMFJ
510(k) Number
FDA Product Code
ELW
EMDN Code
Q01020103 Dental impression polyethers
GMDN Term
Silicone dental impression material
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
872.3660
Market of Registration
Germany
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 3 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class II
SterileEUDAMED
Yes
GUDID
No
Contains LatexEUDAMED
Yes
GUDID
No

Manufacturer details

EUDAMED SRN
DE-MF-000005014

Other devices from Kettenbach GmbH & Co. KG

See all devices from Kettenbach GmbH & Co. KG →

Properties & raw data

Show properties, registry sources and raw records
  • Sterile YesEUDAMEDNoGUDID
  • Single Use
  • Contains Latex YesEUDAMEDNoGUDID
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date
Other properties (18)
  • Implantable: No
  • Reusable: 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
  • Manufacturing Date: No

Sources (2)

  • EUDAMED dd8c4043-8936-4f31-8fc5-184a1475954a 61 fields · synced 22 Oct 2026
  • FDA UDI 745c3120-bd8e-4306-b4bb-39611030f210 37 fields · synced 30 May 2026