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OMNIBotics 4148-1001

by OMNIlife science, Inc.

Ref 4148-1001Model OmniBotics

OMNIBotics 4148-1001 is a device classified as Class IIa in the EU and Class II in the US made by OMNIlife science, Inc., registered in EUDAMED on 28 Oct 2026 (Basic UDI-DI B-00841690199892) and listed in FDA GUDID since 10 Jan 2023 (UDI-DI 00841690199892), active as of 7 Nov 2026.

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

CE MDD

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 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-00841690199892 Basic UDI-DI 00841690199892UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690199892 UDI-DI Date10 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841690199892 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 00841690199892 listed 10 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841690199892
  2. Registered EUDAMED B-00841690199892

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  • Withdrawn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
Self tapping and self drilling bone screw Ø4mm, L150mm, thread 45mm EUDAMED
OMNIBotics GUDID
Generic name
Orthopaedic prosthesis implantation positioning instrument, reusable
Model / Ref / Catalog
4148-1001, OmniBotics
Primary DI / UDI-DI
00841690199892
Basic UDI-DI
B-00841690199892
FDA product code
OLO
EMDN code
L0999 Orthopaedic and traumatological surgery instruments, reusable - other
GMDN term
Orthopaedic prosthesis implantation positioning instrument, reusable
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
EU registration type
Legacy device (under a directive)
EU market of registration
France
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II

Related devices

Category: Orthopaedic prosthesis implantation positioning instrument, reusable

Other devices from OMNIlife science, Inc.

See all devices from OMNIlife science, Inc. →

Properties

  • Sterilise before use
  • Reusable
  • Premarket exempt
Other properties (22, all answered No)