Skip to content

DentSpec

by North Eos Industries, Inc. Taiwan EUDAMEDGUDID

Ref DentSpec-MModel DentSpec

Product code EIFEMDN Z12119085

Regulatory status

as of 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471256836DENJH Basic UDI-DIDate8 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number04712568360408 UDI-DIDate10 Aug 2018ListedStatusIn distribution

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
DentSpec EUDAMED
Eos GUDID
Generic Name
Dental cheek retractor, professional, single-use
Model / Reference
DentSpec EUDAMED
DentSpec-M EUDAMED
DentSpec -MEDIUM GUDID
Primary DI / UDI-DI
04712568360408
Basic UDI-DI
471256836DENJH
FDA Product Code
EIF
EMDN Code
Z12119085 Various dental stomatology instruments - consumables
GMDN Term
Dental cheek retractor, professional, single-use
Device Class
Class I
Regulation Number
872.4565
Market of Registration
Northern Ireland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
DentSpec
DentSpec-M
GUDID
DentSpec -MEDIUM

Manufacturer details

EUDAMED SRN
TW-MF-000007743
Authorised representative
Advena Limited MT-AR-000000234

Other devices from North Eos Industries, Inc.

See all devices from North Eos Industries, Inc. →

Properties & raw data

Show properties, registry sources and raw records
  • Single Use
  • Prescription Use
  • Premarket Exempt
Other properties (21)
  • 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
  • Lot / Batch Number: No
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (2)

  • EUDAMED dff35e34-0577-4c2e-b4a3-c540e398833f 61 fields · synced 22 Oct 2026
  • FDA UDI b8d01e22-6682-46a5-9cd5-26eb554cf5f3 33 fields · synced 30 May 2026