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Bone Profile Guide Pin HNBDG

by Ossvis Co., Ltd.

Ref HNBDG

Bone Profile Guide Pin HNBDG is a Class I device made by Ossvis Co., Ltd., registered in EUDAMED on 5 Jul 2026 (Basic UDI-DI 880987741LI0002J5) and listed in FDA GUDID since 15 Dec 2023 (UDI-DI 08809877419821), active as of 23 Oct 2026.

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

CE MDR

Valid until

No date given

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

Source EUDAMED, GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number880987741LI0002J5 Basic UDI-DI 08809877419821UDI-DIDate5 Jul 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809877419821 UDI-DI Date15 Dec 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 880987741LI0002J5 registered 5 Jul 2026 Active
  • FDA GUDID UDI-DI 08809877419821 listed 15 Dec 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809877419821
  2. Registered EUDAMED 880987741LI0002J5

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  • Withdrawn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
Bone Profile Guide Pin
Generic name
Surgical drill guide, reusable
Device name
Dental Surgical Instrument
Model / reference
HNBDG
Primary DI / UDI-DI
08809877419821
Basic UDI-DI
880987741LI0002J5
FDA product code
NDP
EMDN code
L159099 Odontostomatology instruments, reusable - other
GMDN term
Surgical drill guide, reusable
Device class
Class I
Regulation number
872.3980
EU registration type
Standard device
EU market of registration
Spain
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from Ossvis Co., Ltd.

See all devices from Ossvis Co., Ltd. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Manufacturing date
Other properties (19, all answered No)