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Radiochromic.com

by Radiochromic S.L. Spain EUDAMEDGUDID

Ref Radiochromic.com v3.4, Radiochromic.com v6.0 Product code MWWEMDN Z11010182

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number++B9873X4RJ Basic UDI-DIDate13 Oct 2021RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID NumberB9873X40 UDI-DIDate11 Sep 2021ListedStatusWithdrawn

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 Withdrawn
  • 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
Accelerator system quality assurance device
Model / Reference
Radiochromic.com v3.4 EUDAMED
Radiochromic.com v6.0 EUDAMED
3.4 GUDID
6.0 GUDID
Primary DI / UDI-DI
B9873X40, B9876X00
Basic UDI-DI
++B9873X4RJ, ++B9876X0RR
Direct Marketing DI
B9873X40
B9876X00
FDA Product Code
MWW
EMDN Code
Z11010182 Linear accelerators - software accessories
GMDN Term
Accelerator system quality assurance device
Device Class
Class I EUDAMED
Class II GUDID
Regulation Number
892.5050
Market of Registration
Spain
Commercial Distribution
Not in Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Radiochromic.com v3.4
Radiochromic.com v6.0
GUDID
3.4
6.0
Device ClassEUDAMED
Class I
GUDID
Class II

Manufacturer details

EUDAMED SRN
ES-MF-000001178

Other devices from Radiochromic S.L.

Properties & raw data

Show properties, registry sources and raw records
  • Premarket Exempt
  • Lot / Batch Number
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
  • Serial Number: No
  • Expiration Date: No
  • Manufacturing Date: No

Sources (4)

  • EUDAMED 1a57bc38-27f8-40f7-8474-221296340325 61 fields · synced 24 Oct 2026
  • EUDAMED B9876X00|++B9876X0RR 61 fields · synced 19 May 2026
  • FDA UDI 6b351a7a-a7f8-4cc4-a9bc-ddd837a48dd4 34 fields · synced 30 May 2026
  • FDA UDI 86927ee7-bb71-4b93-9d8d-d02ffffccbb6 34 fields · synced 23 Oct 2026