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EndoNaut (Standalone) SW 1.2

by Therenva Sas

Ref EndoNaut (Standalone) SW v1.2.xModel v1.2.x

EndoNaut (Standalone) SW 1.2 is a medical device (EU MDR Class IIb; FDA Class II; EMDN category surgical navigation instruments - medical device software) made by Therenva Sas, registered in EUDAMED on 5 Nov 2026 (Basic UDI-DI 376026248EndoNautSWEA), cleared under FDA 510(k) K222070 on 25 Oct 2022 and listed in FDA GUDID since 11 Dec 2023 (UDI-DI 03760262480022), active as of 7 Nov 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 7 Nov 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K222070

FDA submission, from GUDID

Trust

Unverified

Source EUDAMED, GUDID, synced 7 Nov 2026.

Regulatory status

as of registry sync 7 Nov 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number376026248EndoNautSWEA Basic UDI-DI 03760262480022UDI-DIDate5 Nov 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number03760262480022 UDI-DI Date11 Dec 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK222070 Date25 Oct 2022DecidedStatusActive

Official records

Across registries

3 registries list this device

  • EUDAMED Basic UDI-DI 376026248EndoNautSWEA registered 5 Nov 2026 Active
  • FDA 510(k) K222070 decided 25 Oct 2022 Active
  • FDA GUDID UDI-DI 03760262480022 listed 11 Dec 2023 Listed

Timeline

3 dated events

  1. Cleared FDA 510(k) K222070
  2. Listed FDA GUDID 03760262480022
  3. Registered EUDAMED 376026248EndoNautSWEA

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  • Withdrawn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

Trade name
EndoNaut EUDAMED
EndoNaut (Standalone) SW GUDID
Generic name
Radiology DICOM image processing application software
Model / reference
v1.2.x EUDAMED
EndoNaut (Standalone) SW v1.2.x EUDAMED
1.2 GUDID
Primary DI / UDI-DI
03760262480022
Basic UDI-DI
376026248EndoNautSWEA
Direct marketing DI
03760262480022
510(k) Number
FDA product code
OWB, LLZ
EMDN code
Z12011492 Surgical navigation instruments - medical device software
GMDN term
Radiology DICOM image processing application software
Device class
Class IIb EUDAMED
Class II GUDID
Regulation number
892.1650, 892.2050
Special device type
Software
EU registration type
Standard device
EU market of registration
France
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / referenceEUDAMED
v1.2.x
EndoNaut (Standalone) SW v1.2.x
GUDID
1.2
Device classEUDAMED
Class IIb
GUDID
Class II

Device class is stated on each registry's own scale: Class IIb 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: Radiology DICOM image processing application software

Cleared under the same submission (K222070)

Similar devices in this category

Other devices filed under SURGICAL NAVIGATION INSTRUMENTS - MEDICAL DEVICE SOFTWARE.

Other devices from Therenva Sas

See all devices from Therenva Sas →

Properties

  • Measuring function
  • Prescription use
  • Manufacturing date
Other properties (22, all answered No)