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Gating Module RT - Varian TrueBeam

by Dyn'r EUDAMEDGUDID

Withdrawn No longer placed on the EU market

Ref SDX0366N

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDD EUDAMED NumberB-03760290230149 Basic UDI-DIDate19 May 2026RegisteredStatusWithdrawn No longer placed on the EU market
United StatesGUDID listing GUDID Number03760290230149 UDI-DIDate2 Oct 2018ListedStatusListed GUDID: in commercial distribution

Coverage

2 jurisdictions

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  • Withdrawn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  • European Union CE/MDD Withdrawn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

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.

Recalls

0 recalls · FDA

No FDA recalls on record, checked 25 Oct 2026.

Specification

EUDAMED · GUDID

Trade Name
Gating Module RT - Varian TrueBeam EUDAMED
SDX System GUDID
Generic Name
Real-time position management respiratory gating system, spirometry
Model / Ref / Catalog
SDX0366N EUDAMED
V1.0 GUDID
SDX0366V1.0 GUDID
Primary DI / UDI-DI
03760290230149
Basic UDI-DI
B-03760290230149
510(k) Number
FDA Product Code
LHN, IYE
EMDN Code
Z11019099 Various radiotherapy and radiosurgery instruments - other
GMDN Term
Real-time position management respiratory gating system, spirometry
Device Class
Class IIb EUDAMED
Class II GUDID
Regulation Number
892.5050
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 2 fields differ

FieldEUDAMEDGUDID
Model / ReferenceEUDAMED
SDX0366N
GUDID
V1.0
Device ClassEUDAMED
Class IIb
GUDID
Class II

Manufacturer details

EUDAMED SRN
FR-MF-000001876

Other devices from Dyn'r

See all devices from Dyn'r →

Properties

  • Measuring Function
  • Serial Number
  • Manufacturing Date

Other properties (19)

  • 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
  • Incorporates Medicinal Product: No
  • Prescription Use: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Lot / Batch Number: No
  • Expiration Date: No