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Guide OGURL

by OSSTEM IMPLANT Co., Ltd. 2 variants

Part of a family of 11 devices: see the family page

Ref OGURL

Guide OGURL is a Class I device made by OSSTEM IMPLANT Co., Ltd., registered in EUDAMED on 13 Feb 2026 (Basic UDI-DI 88000406CLASSIRGM) and listed in FDA GUDID since 8 Dec 2022 (UDI-DI 08800000945095), active as of 24 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 24 Oct 2026.

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number88000406CLASSIRGM Basic UDI-DI 08800000945095UDI-DIDate13 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08800000945095 UDI-DI Date8 Dec 2022ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000406CLASSIRGM registered 13 Feb 2026 Active
  • FDA GUDID UDI-DI 08800000945095 listed 8 Dec 2022 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08800000945095
  2. Registered EUDAMED 88000406CLASSIRGM

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  • Withdrawn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
Guide
Generic name
Surgical drill guide, reusable
Device name
Reusable Surgical Instrument System
Model / reference
OGURL
Primary DI / UDI-DI
08800000945095
Basic UDI-DI
88000406CLASSIRGM
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
Czechia
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Related devices

Category: Surgical drill guide, reusable

Similar devices in this category

Other devices filed under ODONTOSTOMATOLOGY INSTRUMENTS, REUSABLE - OTHER.

Other devices from OSSTEM IMPLANT Co., Ltd.

See all devices from OSSTEM IMPLANT Co., Ltd. →

Properties

  • Sterilise before use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (18, all answered No)