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Vesalius QUANTUM SMART

by Telea Electronic Engineering S.r.l.

Ref 2501034, 2501019

Active European Union. Also listed in GUDID (US), not in commercial distribution.

CE MDR

Valid until

Not listed

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

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 24 Oct 2026. What this means

Regulatory status

as of registry sync 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number803405529VESJB Basic UDI-DI Date7 Apr 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number08034055291443 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not in commercial distribution

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States GUDID listing Listed

Specification

EUDAMED · GUDID

Trade Name
Vesalius QUANTUM SMART EUDAMED
Vesalius QUANTUM EUDAMED
VESALIUS Molecular Resonance Generator GUDID
Generic Name
Electrosurgical system generator
Device Name
Vesalius
Model / Ref / Catalog
2501034, 2501019, VESALIUS QUANTUM
Primary DI / UDI-DI
08034055291443, 08034055290163
Basic UDI-DI
803405529VESJB
Direct Marketing DI
08034055291443
08034055290163
FDA Product Code
GEI
EMDN Code
Z12010905 Radiosurgical units
GMDN Term
Electrosurgical system generator
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
878.4400
EU market of registration
Italy
GUDID distribution status
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
2501034
2501019
GUDID
VESALIUS QUANTUM
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
IT-MF-000009973

Other devices from Telea Electronic Engineering S.r.l.

See all devices from Telea Electronic Engineering S.r.l. →

Properties

  • Prescription Use
  • Lot / Batch Number
  • Serial Number
  • Manufacturing Date

Other properties (20)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Expiration Date: No