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EosOtoSpec IV

by North Eos Industries, Inc. Taiwan EUDAMEDGUDID

Ref EosOtoSpec IV-Gutter-Veterinary-4mmModel NasalSpec Product code EPYEMDN Z12149006

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471256836ENTKV Basic UDI-DIDate8 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number04712568360859 UDI-DIDate15 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 AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • 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
EosOtoSpec IV EUDAMED
Eos GUDID
Generic Name
Ear speculum, single-use
Model / Reference
NasalSpec EUDAMED
EosOtoSpec IV-Gutter-Veterinary-4mm EUDAMED
EosOtoSpec IV-GUTTER-VET. 4MM(HEINE) GUDID
Description
EOS BRAND DISPOSABLE OTOSCOPE IV- GUTTER-Veterinary 4MM (HEINE)
Primary DI / UDI-DI
04712568360859
Basic UDI-DI
471256836ENTKV
Direct Marketing DI
04712568360859
FDA Product Code
EPY
EMDN Code
Z12149006 Direct outpatient otoscopes
GMDN Term
Ear speculum, single-use
Device Class
Class I
Regulation Number
878.1800
Market of Registration
Northern Ireland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NasalSpec
EosOtoSpec IV-Gutter-Veterinary-4mm
GUDID
EosOtoSpec IV-GUTTER-VET. 4MM(HEINE)

Manufacturer details

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

Other devices from North Eos Industries, Inc.

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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 67b87ead-67db-42d6-bb8a-d7509ed85a33 61 fields · synced 22 Oct 2026
  • FDA UDI e6ce3591-47ce-4419-a130-dffb8cbbac55 33 fields · synced 30 May 2026