Skip to content

Osseous

by Eon Meditech Pvt. Ltd 144 variants

Ref E3146UUSModel 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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08906039310573 Basic UDI-DI 08906039310573UDI-DIDate4 Dec 2025RegisteredStatusActive
United StatesGUDID listing GUDID Number08906039310573 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  • Withdrawn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 Silicone Sheets GUDID
Generic Name
Silicone-sheet tissue reconstructive material
Device Name
Silicone Sheets (Thickness: 0.13mm)
Model / Reference
Rhinology Product, E3146UUS
Description
"Internal Nasal Splint enhances patient comfort by Allowing nasal breathing while providing support of nasal Septal structure. "
Primary DI / UDI-DI
08906039310573
Basic UDI-DI
B-08906039310573
FDA Product Code
EPP
EMDN Code
Q0399 ENT devices - other
GMDN Term
Silicone-sheet tissue reconstructive material
Device Class
Class IIa EUDAMED
Class I GUDID
Regulation Number
874.5800
EU market of registration
Italy
GUDID distribution status
In Commercial Distribution
Size
Height — 0.13 Millimeter

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class IIa
GUDID
Class I
ImplantableEUDAMED
No
GUDID
Yes

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
  • Implantable NoEUDAMEDYesGUDID
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • 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