Skip to content

MS Removal Tool OMRT25E

by OSSTEM IMPLANT Co., Ltd.

Ref OMRT25E

MS Removal Tool OMRT25E is a Class I device made by OSSTEM IMPLANT Co., Ltd., registered in EUDAMED on 10 Feb 2026 (Basic UDI-DI 88000406CLASSIBS25V) and listed in FDA GUDID since 1 Nov 2023 (UDI-DI 08809892362188), 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 Number88000406CLASSIBS25V Basic UDI-DI 08809892362188UDI-DIDate10 Feb 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08809892362188 UDI-DI Date1 Nov 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI 88000406CLASSIBS25V registered 10 Feb 2026 Active
  • FDA GUDID UDI-DI 08809892362188 listed 1 Nov 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 08809892362188
  2. Registered EUDAMED 88000406CLASSIBS25V

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  • Withdrawn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
MS Removal Tool
Generic name
Surgical screwdriver, single-use
Device name
Instrument System
Model / reference
OMRT25E
Primary DI / UDI-DI
08809892362188
Basic UDI-DI
88000406CLASSIBS25V
FDA product code
NDP
EMDN code
Q010599 Dental instruments, single-use - other
GMDN term
Surgical screwdriver, single-use
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 screwdriver, single-use

Similar devices in this category

Other devices filed under DENTAL INSTRUMENTS, SINGLE-USE - OTHER.

Other devices from OSSTEM IMPLANT Co., Ltd.

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

Properties

  • Sterilise before use
  • Single use
  • Reusable
  • Prescription use
  • Premarket exempt
  • Lot / batch number
  • Serial number
  • Manufacturing date
Other properties (17, all answered No)