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Dose+

by MVision AI Oy Finland EUDAMED510(k)GUDID

Ref 06429830064237 Model Dose+ 1.0

Product code MUJEMDN Z11010292

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing GUDID Number06429830064237 UDI-DIDate3 Oct 2025ListedStatusIn distribution
United StatesFDA 510(k) 510(k) NumberK250064 Date4 Sep 2025IssuedStatusActive
European UnionCE/MDR EUDAMED Number642983006423Dose1.0DH Basic UDI-DIDate14 Mar 2025RegisteredStatusActive

Coverage

2 jurisdictions

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenFinlandFinlandUnited States of AmericaUnited States of AmericaUnited States of AmericaSwedenSwedenLatviaEstoniaUnited States of AmericaDenmarkLithuaniaIrelandNetherlandsGermanyGermanyPolandPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaPolandUnited 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 AmericaFranceFranceAustriaHungaryRomaniaUnited 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 AmericaFranceFranceSloveniaBulgariaUnited 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 AmericaPortugalSpainSpainItalyUnited 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 AmericaSpainSpainCroatiaGreeceUnited 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 AmericaMaltaCyprusUnited 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 America
  • Active
  • Not covered
  • United States FDA 510(k) Active
  • European Union CE/MDR Active

Recalls: none on record (FDA, checked 23 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · 510(k) · GUDID · synced 23 Oct 2026

Generic Name
Radiation therapy software
Model / Reference
Dose+ 1.0 EUDAMED
06429830064237 EUDAMED
1.0 GUDID
Primary DI / UDI-DI
06429830064237
Basic UDI-DI
642983006423Dose1.0DH
Direct Marketing DI
06429830064237
510(k) Number
FDA Product Code
MUJ
EMDN Code
Z11010292 Instruments for radiotherapy simulation - medical device software
GMDN Term
Radiation therapy software
Device Class
Class IIa EUDAMED
Class II GUDID
Regulation Number
892.5050
Special Device Type
Software
Market of Registration
Finland
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Dose+ 1.0
06429830064237
GUDID
1.0
Device ClassEUDAMED
Class IIa
GUDID
Class II

Manufacturer details

EUDAMED SRN
FI-MF-000013082

Other devices from Mvision AI Oy

Properties & raw data

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

Sources (3)

  • EUDAMED c2f9d975-a3df-4c4c-b43c-a8144f4e8fbf 61 fields · synced 23 Oct 2026
  • FDA UDI 75ab9fe9-474d-4d28-94ba-621ed8fef28e 34 fields · synced 22 Oct 2026
  • FDA 510(k) K250064 1 fields · synced 18 May 2026