Skip to content

Octabone® Syringe

by Chiyewon Co., LTD. 6 variants

Ref S25-1217

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-08809490621892 Basic UDI-DI 08809490621892UDI-DIDate3 Mar 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809490621892 UDI-DI Date2 Feb 2026ListedStatusListed 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  • Withdrawn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
Octabone® Syringe EUDAMED
Octabone GUDID
Generic Name
Dental bone void filling material, animal-derived
Model / Reference
S25-1217
Primary DI / UDI-DI
08809490621892
Basic UDI-DI
B-08809490621892
FDA Product Code
NPM
EMDN Code
Q010302 Dental graft devices
GMDN Term
Dental bone void filling material, animal-derived
Device Class
Class III EUDAMED
Class II GUDID
Regulation Number
872.3930
EU market of registration
Portugal
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device ClassEUDAMED
Class III
GUDID
Class II

Manufacturer details

EUDAMED SRN
KR-MF-000022264
Authorised representative
Obelis s.a. BE-AR-000000106

Other devices from Chiyewon Co., LTD.

See all devices from Chiyewon Co., LTD. →

Properties

  • Sterile
  • Single Use
  • Implantable
  • Animal Tissues
  • Lot / Batch Number
  • Serial Number
  • Expiration Date
  • Manufacturing Date

Other properties (14)

  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No