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RIWOtrack Flexsensor

by Fiagon GmbH

Ref N 01 2950Model RIWOtrack Navigation System

RIWOtrack Flexsensor (N 01 2950) is a multi-purpose stereotactic surgery system (EU MDR Class IIa; FDA Class II; FDA product code OLO, Orthopedic Stereotaxic Instrument) made by Fiagon GmbH, registered in EUDAMED on 22 Nov 2024 (Basic UDI-DI 426075993S1009E), cleared under FDA 510(k) K230700 on 20 Nov 2023 and listed in FDA GUDID since 5 Jan 2024 (UDI-DI 04260759930096), active as of 25 Oct 2026.

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 25 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K230700

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 25 Oct 2026.

Regulatory status

as of registry sync 25 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number426075993S1009E Basic UDI-DI 04260759930096UDI-DIDate22 Nov 2024RegisteredStatusActive
United StatesGUDID listing GUDID Number04260759930096 UDI-DI Date5 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k) GUDID from GUDID NumberK230700 Date20 Nov 2023IssuedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 426075993S1009E registered 22 Nov 2024 Active
  • FDA 510(k) K230700 decided 20 Nov 2023 Active
  • FDA GUDID UDI-DI 04260759930096 listed 5 Jan 2024 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K230700
  2. Listed FDA GUDID 04260759930096
  3. Registered EUDAMED 426075993S1009E

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Generic name
Multi-purpose stereotactic surgery system
Model / Ref / Catalog
RIWOtrack Navigation System EUDAMED
N 01 2950 EUDAMED
N012950 GUDID
Primary DI / UDI-DI
04260759930096
Basic UDI-DI
426075993S1009E
Direct marketing DI
04260759930096
510(k) Number
FDA product code
OLO
EMDN code
Z12011401 Surgical navigation system
GMDN term
Multi-purpose stereotactic surgery system
Device class
Class IIa EUDAMED
Class II GUDID
Regulation number
882.4560
System or procedure pack
System which is a device in itself
EU registration type
Standard device
EU market of registration
Germany
GUDID distribution status
In Commercial Distribution
Sterilisation method
Moist Heat or Steam Sterilization
MRI safety
MR Unsafe

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
RIWOtrack Navigation System
N 01 2950
GUDID
N012950
Device classEUDAMED
Class IIa
GUDID
Class II

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.

Manufacturer details

EUDAMED SRN
DE-MF-000010763

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION SYSTEM.

Other devices from Fiagon GmbH

See all devices from Fiagon GmbH →

Properties

  • Sterilise before use
  • Prescription use
  • Serial number
  • Manufacturing date
Other properties (21, all answered No)