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EndoNaut (System)

by Therenva France EUDAMEDGUDID

Ref EN SW v1.2 and EN WK TS1CA2DS1-2 Product code OWBEMDN Z12011401

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03760262480046 UDI-DIDate6 May 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED Number376026248EndoNautSystem69 Basic UDI-DIDate4 May 2026RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 24 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 24 Oct 2026

Generic Name
Surgical planning/navigation-enhancement system
Model / Reference
EN SW v1.2 and EN WK TS1CA2DS1-2 EUDAMED
1.2 GUDID
Primary DI / UDI-DI
03760262480046
Basic UDI-DI
376026248EndoNautSystem69
510(k) Number
FDA Product Code
OWB, LLZ
EMDN Code
Z12011401 Surgical navigation system
GMDN Term
Surgical planning/navigation-enhancement system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.1650, 892.2050
Medical Purpose
EndoNaut System is an image fusion solution intended to assist X-ray fluoroscopy-guided procedures in the positioning of surgical instruments and endovascular devices.
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
EN SW v1.2 and EN WK TS1CA2DS1-2
GUDID
1.2
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-PR-000052006

Other devices from Therenva Sas

See all devices from Therenva Sas →

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date
Other properties (10)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED be8ca8b0-b4f8-4e58-acd7-7b12a553a72e 61 fields · synced 24 Oct 2026
  • FDA UDI 73248b72-8afc-4613-b975-14467baada88 34 fields · synced 23 Oct 2026