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OMNIBotics NV-CRD02

by OMNIlife science, Inc.

Ref NV-CRD02Model OmniBotics

OMNIBotics NV-CRD02 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-00841690194880) and listed in FDA GUDID since 10 Jan 2023 (UDI-DI 00841690194880), 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-00841690194880 Basic UDI-DI 00841690194880UDI-DIDate28 Oct 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number00841690194880 UDI-DI Date10 Jan 2023ListedStatusListed GUDID: in commercial distribution

Official records

Across registries

2 registries list this device

  • EUDAMED Basic UDI-DI B-00841690194880 registered 28 Oct 2026 Active
  • FDA GUDID UDI-DI 00841690194880 listed 10 Jan 2023 Listed

Timeline

2 dated events

  1. Listed FDA GUDID 00841690194880
  2. Registered EUDAMED B-00841690194880

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  • Withdrawn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
OMNIBotics Station Power Cord, EU EUDAMED
OMNIBotics GUDID
Generic name
Robotic surgical navigation system
Model / Ref / Catalog
NV-CRD02, OmniBotics
Primary DI / UDI-DI
00841690194880
Basic UDI-DI
B-00841690194880
FDA product code
OLO
EMDN code
Z12130480 Stereotactic orthopaedic surgery instruments - hardware accessories
GMDN term
Robotic surgical navigation system
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 · 2 fields differ

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Sterilise before useEUDAMED
No
GUDID
Yes

Registry differences

EUDAMED and FDA GUDID describe the same product (same UDI-DI) and state different values:

  • Sterilise before use UDI-DI 00841690194880: EUDAMED states No, FDA GUDID states Yes.

Device class is stated on each registry's own scale: Class IIa in the EU (EUDAMED), Class II in the US (FDA GUDID). EU and US classes are different schemes, so this is not a disagreement.

Related devices

Category: Robotic surgical navigation system

Similar devices in this category

Other devices filed under STEREOTACTIC ORTHOPAEDIC SURGERY INSTRUMENTS - HARDWARE ACCESSORIES.

Other devices from OMNIlife science, Inc.

See all devices from OMNIlife science, Inc. →

Properties

  • Sterilise before use NoEUDAMEDYesGUDID
  • Premarket exempt
Other properties (23, all answered No)