Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008317830

FEI Number

3008317830

Entity Name

DYN'R

City/State/Country

GARDANNE. Bouches-du-Rhone, FR

Establishment Address

1480 Avenue Armenie Pole Yvon Morandat, GARDANNE. Bouches-du-Rhone 13120, FR

Establishment Type(s)

Export Device to the United States But Perform No Other Operation on Device

Owner / Operator

Dyn'R (Owner Number: 10031870)

Owner / Operator Contact Address

1480 Avenue Armenie, Pole Yvon Morandat, Gardanne, FR-13 13120, FR

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

N/A

PMA Number

N/A

All Registered Proprietary Names

SDX System SDX System SDX System with Gating Module SDX System special edition with Gating Module SDX Calibration Syringe Nose Clip for SDX System

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
BZG	Spirometer, Diagnostic	Anesthesiology	Class 2	868.1840	2011-02-27
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2010-03-17
LHN	System, Radiation Therapy, Charged-Particle, Medical	Radiology	Class 2	892.5050	2016-09-23
IYE	Accelerator, Linear, Medical	Radiology	Class 2	892.5050	2016-09-23
BXW	Calibrator, Volume, Gas	Anesthesiology	Class 1	868.1870	2010-12-06
BXJ	Clip, Nose	Anesthesiology	Class 1	868.6225	2010-12-06

Official Correspondent

Gordon Fairbairn

US Agent Details

Michel Van Welden Email: michel.vanwelden@mac.com Phone: (305) 4908950

Related Public Records

Same Entity

Dyn'R

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K923989	Sensor Medics Corp.	SENSORMEDICS MODEL 6200 AUTOBOX DL	1993-08-09
K071992	Varian Medical Systems	HIGH-DEFINITION 120 MULTILEAF COLLIMATOR (HD120 MLC)	2007-08-15
K253962	Radformation, Inc.	ClearCheck (RADCC V2.7)	2026-04-03
K003779	Arplay Medical S.A.	IMMOBILIZATION SYSTEM FOR ENT	2001-07-12

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0004-2019	Varian Medical Systems	2	TrueBeam Radiotherapy Delivery System version 2.0 and 2.5 EDGE Radiotherapy Delivery System version 2.0 and 2.5 Product Usage: The TrueBeam delivery systems are intended to provide radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0005-2019	Varian Medical Systems	2	VitalBeam Radiotherapy Delivery System Version 2.5 Product Usage: The VitalBeam delivery systems are intended to provide precision radiotherapy and stereotactic radiosurgery for lesions, tumors, and conditions anywhere in the body where radiation treatment is indicated.
Z-0020-2015	N/A	2	Proteus 235 Proton Therapy System for cancer treatment.
Z-0035-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Standard Treatment Couch). Synchrony Respiratory Tracking System, a Radiation Therapy Device, Model Numbers: 026429, 028185. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA
Z-0036-2012	Accuray Incorporated	2	CyberKnife Robotic Radiosurgery System, Synchrony Respiratory Tracking System (Robocouch Patient Positioning System), a Radiation Therapy Device. Model Numbers: 026430, 028186. Product is manufactured and distributed by Accuray, Inc., Sunnyvale, CA

Similar Registrations

Registration Number	Establishment Name	Location
3036774597	TECHNOPULM, LTD.	Petah Tikva Central, IL
3006895489	MEDIKRO OY	Kuopio Pohjois-Savo, FI
3014128536	MEDCHIP SOLUTIONS LIMITED	Chatham Kent, GB
3038761440	Corsano Health SA	Plan-les-Ouates Geneve, CH
3016595211	DYNAMIC EMS LTD	Dalgety Bay Fife, GB

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008317830. Last updated year: 2026. Please use registration number 3008317830 when referencing this establishment in official correspondence.