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Osseous

by Eon Meditech Pvt. Ltd 144 variants

Ref E3148FTPModel Rhinology Product

Active European Union. Also listed in GUDID (US).

CE MDD

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 25 Oct 2026. What this means

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08906039315486 Basic UDI-DI 08906039315486UDI-DIDate5 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08906039315486 UDI-DI Date3 Jul 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  • Withdrawn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/MDD Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Osseous EUDAMED
OSSEOUS Internal Nasal Bi-valve Splint - Thin Pediatric GUDID
Generic Name
Intranasal splint, non-biodegradable
Device Name
Internal Nasal Bi-valve Splint - Thin Pediatric (Fluoroplastic)
Model / Reference
Rhinology Product, E3148FTP
Primary DI / UDI-DI
08906039315486
Basic UDI-DI
B-08906039315486
FDA Product Code
EPP
EMDN Code
Q0399 ENT devices - other
GMDN Term
Intranasal splint, non-biodegradable
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.5800
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Length — 42 Millimeter
Width — 27 Millimeter
Height — 0.25 Millimeter

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I

Manufacturer details

EUDAMED SRN
IN-MF-000014457
Authorised representative
CMC Medical Devices & Drugs SL ES-AR-000000293

Other devices from Eon Meditech Pvt. Ltd

See all devices from Eon Meditech Pvt. Ltd →

Properties

  • Sterile
  • Single Use
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (15)

  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Serial Number: No