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Xstrahl Photoelectric Therapy System

by Xstrahl, Ltd. United Kingdom EUDAMEDGUDID

Ref X80Model Xstrahl 80 Therapeutic X-Ray System (RADiant)

Product code JADEMDN Z11019099

Regulatory status

as of 24 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-05060494200008 Basic UDI-DIDate26 Jun 2026RegisteredStatusActive
United StatesGUDID listing GUDID Number05060494200008 UDI-DIDate3 Jul 2017ListedStatusIn distribution

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
  • Expiring (legacy directive)
  • Listed
  • Not covered
  • European Union CE/MDD Expiring (legacy directive)
  • United States GUDID listing Listed

Recalls: none on record (FDA, checked 11 Oct 2026)

Certificates: none listed in EUDAMED

Specification

EUDAMED · GUDID · synced 11 Oct 2026

Trade Name
Xstrahl 80 Therapeutic X-Ray System (RADiant) EUDAMED
Xstrahl Photoelectric Therapy System GUDID
Generic Name
Stationary orthovoltage therapeutic x-ray system
Model / Reference
Xstrahl 80 Therapeutic X-Ray System (RADiant) EUDAMED
X80 EUDAMED
Xstrahl Photoelectric Therapy System GUDID
Primary DI / UDI-DI
05060494200008
Basic UDI-DI
B-05060494200008
FDA Product Code
JAD
EMDN Code
Z11019099 Various radiotherapy and radiosurgery instruments - other
GMDN Term
Stationary orthovoltage therapeutic x-ray system
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.5900
Market of Registration
Sweden
Commercial Distribution
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
Xstrahl 80 Therapeutic X-Ray System (RADiant)
X80
GUDID
Xstrahl Photoelectric Therapy System
Device ClassEUDAMED
Class IIb
GUDID
Class II

Related devices

Category: Stationary orthovoltage therapeutic x-ray system

Properties & raw data

Show properties, registry sources and raw records
  • Prescription Use
  • Convenience Kit
  • Serial Number
  • Manufacturing Date
Other properties (18)
  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No

Sources (2)

  • FDA UDI 37bbc21d-e5e5-4896-83a9-0566c9eed009 33 fields · synced 11 Oct 2026
  • EUDAMED 05060494200008|B-05060494200008 61 fields · synced 10 Oct 2026