Skip to content

Radiance v5

by Gmv Soluciones Globales Inernet S.A.U. Spain EUDAMEDGUDID

Ref Radiance v5

Product code MUJEMDN Z11010401

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number08436567540024 UDI-DIDate8 Apr 2026ListedStatusIn distribution
European UnionCE/MDR EUDAMED NumberES25/00001036 Date1 Oct 2025IssuedStatusActive expires 1 Oct 2030

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 23 Oct 2026)

Certificates

1 certificate · EUDAMED

EUDAMED certificates (1)
  • ES25/00001036 Issued

    Quality management system EU MDR

    Notified body
    Notified body 1639
    Issued
    1 Oct 2025
    Expires
    1 Oct 2030

Specification

EUDAMED · GUDID · synced 23 Oct 2026

Trade Name
Radiance v5 EUDAMED
Radiance GUDID
Generic Name
Radiation therapy software
Model / Reference
Radiance v5 EUDAMED
5 GUDID
Primary DI / UDI-DI
08436567540024
Basic UDI-DI
843656754RADIANCEA2
510(k) Number
FDA Product Code
MUJ
EMDN Code
Z11010401 Radiotherapy treatment planning systems
GMDN Term
Radiation therapy software
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.5050
Special Device Type
Software
Market of Registration
Spain
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Radiance v5
GUDID
5
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
ES-MF-000000685

Other devices from Gmv Soluciones Globales Inernet S.A.U.

  • radiance v4

    Class IIb

Properties & raw data

Show properties, registry sources and raw records
  • Lot / Batch Number
  • Manufacturing Date
Other properties (22)
  • 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
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No

Sources (2)

  • EUDAMED 693e5748-1dfb-44c5-9071-1abc2b7d9655 61 fields · synced 23 Oct 2026
  • FDA UDI caf70567-4427-438b-bb88-4b24c7cf63ad 34 fields · synced 23 Oct 2026