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EndoNaut (System) MHS (Mobile Hybrid Solution)

by Therenva France EUDAMEDGUDID

Ref EndoNaut (System) MHS (Mobile Hybrid Solution)

Product code OWBEMDN Z12011401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number03760262480084 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 AmericaSwedenFinlandFinlandSwedenFinlandFinlandSwedenSwedenLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandFranceFranceAustriaHungaryRomaniaFranceFranceSloveniaBulgariaPortugalSpainSpainItalySpainSpainCroatiaGreeceMaltaCyprus
  • Active
  • Listed
  • 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

Trade Name
EndoNaut (System) MHS (Mobile Hybrid Solution) EUDAMED
EndoNaut System MHS GUDID
Generic Name
Surgical planning/navigation-enhancement system
Model / Reference
EndoNaut (System) MHS (Mobile Hybrid Solution) EUDAMED
1.2 GUDID
Primary DI / UDI-DI
03760262480084
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
EndoNaut (System) MHS (Mobile Hybrid Solution)
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
  • Serial Number
  • Manufacturing Date
Other properties (11)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED f309171c-2f86-41ab-b880-0380ea29a062 61 fields · synced 24 Oct 2026
  • FDA UDI 4c6cb7bb-a28e-4b0c-b863-d1b7e9afa040 34 fields · synced 23 Oct 2026