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EosOtoSpec I

by North Eos Industries, Inc. 3 variants

Ref EosOtoSpec I(Keeler)-3.5mmModel NasalSpec

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number471256836ENTKV Basic UDI-DI 04712568360545UDI-DIDate8 Nov 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number04712568360545 UDI-DI Date15 Aug 2018ListedStatusListed 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  • Withdrawn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
EosOtoSpec I EUDAMED
Eos GUDID
Generic Name
Ear speculum, single-use
Model / Reference
NasalSpec EUDAMED
EosOtoSpec I(Keeler)-3.5mm EUDAMED
EosOtoSpec I-3.5MM (Keeler) GUDID
Primary DI / UDI-DI
04712568360545
Basic UDI-DI
471256836ENTKV
Direct Marketing DI
04712568360545
FDA Product Code
EPY
EMDN Code
Z12149006 Direct outpatient otoscopes
GMDN Term
Ear speculum, single-use
Device Class
Class I
Regulation Number
878.1800
EU market of registration
Northern Ireland
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
NasalSpec
EosOtoSpec I(Keeler)-3.5mm
GUDID
EosOtoSpec I-3.5MM (Keeler)
SterileEUDAMED
No
GUDID
Yes

Manufacturer details

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

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See all devices from North Eos Industries, Inc. →

Properties

  • Sterile NoEUDAMEDYesGUDID
  • Single Use
  • Prescription Use
  • Premarket Exempt

Other properties (20)

  • 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