Fabricant

Varian Medical Systems

États-UnisEntités : Varian Medical Systems, Inc.

Marchés : France · Allemagne · Belgique · Finlande · Pays-Bas · États-Unis

Autorisations : UE – classe I, IIa, IIb · États-Unis (FDA) – 510(k) : 206 · classe I, II · dernière en 2026 · voir sur le site de la FDA

Marchés publics remportés : France 36 · Allemagne 6 · Finlande 2 · Belgique 1

Mandataire UE : Siemens Healthineers Nederland B.V. (Pays-Bas)

19 catégories, 227 modèles dont 224 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Brachytherapy radiation systems - hardware accessories	Z11010380	3D Interstitial Ring Applicator Set 60°3 réf. 3D Interstitial Ring Applicator Set 90°3 réf. 3D-FSD interstitial ovoid pair for 20 mm spread, with 4 needle guide holes each ovoid3 réf. Aarhus Applicator Set3 réf. Adapter pin for GYN templates3 réf. 180 autres Advanced Breast Template System3 réf. Allen key, 2.0 mm wrench size Allen Wrench 2mm3 réf. Applicator and Dilator for Proctoscope ø26 mm3 réf. Applicator probe 3mm diameter x 320mm length, straight93/42 Applicator probe, ø 6.3 mm x 320 mm, curved 15°, 30 mm93/42 Applicator probe, ø 6.3 mm x 320 mm, curved 15°, 50 mm93/42 Applicator probe, ø 6.3 mm x 320 mm, curved 15°, 70 mm93/42 Applicator probe, ø 6.3 mm x 320 mm, curved 30°, 30 mm93/42 Applicator probe, ø 6.3 mm x 320 mm, curved 30°, 50 mm93/42 Applicator probe, ø 6.3 mm x 320 mm, curved 30°, 70 mm93/42 Applicator probe, ø 6.3 mm x 320 mm, straight, 30 mm93/42 Applicator probe, ø 6.3 mm x 320 mm, straight, 40 mm93/42 Applicator probe, ø 6.3 mm x 320 mm, straight, 50 mm93/42 Applicator probe, ø 6.3 mm x 320 mm, straight, 70 mm93/42 Applicator probe, ø 6.3 mm x 320 mm,curved 15°, 40 mm93/42 Applicator probe, ø 6.3 mm x 320 mm,curved 15°, 60 mm93/42 Applicator probe, ø 6.3 mm x 320 mm,curved 15°, 80 mm93/42 Applicator probe, ø 6.3 mm x 320 mm,curved 30°, 40 mm93/42 Applicator probe, ø 6.3 mm x 320 mm,curved 30°, 60 mm93/42 Applicator probe, ø 6.3 mm x 320 mm,curved 30°, 80 mm93/42 Applicator probe, ø 6.3 mm x 320 mm,straight, 60 mm93/42 Applicator probe, ø 6.3 mm x 320 mm,straight, 80 mm93/42 Assembly module, CT/ MR GM110129103 réf. Bite protector for intraluminal applicators3 réf. Bite protector ø10mm with strap Esophagus Bougie Set93/42 Bite protector ø12mm with strap Esophagus Bougie Set93/42 Bite protector ø14mm with strap Esophagus Bougie Set93/42 Bite protector ø8mm with strap Esophagus Bougie Set93/42 Blue locking collets for 2.0 mm needles (pack of 25)2 réf. Bracket for ring applicator for flexible fixation GYN3 réf. Catheter Surface Flap Applicator Set2 réf. Catheter Transfer Guide Tube Set, Channels Numbered 1-103 réf. Central fixation screw for intrauterine probe GM110009803 réf. Cervical sleeve IU ø6.4mm, 30mm, with marker3 réf. Cervical sleeve, 3mm aperture, 20mm length, single use Cervical sleeves93/42 Cervical sleeve, 3mm aperture, 40mm length, single use Cervical sleeves93/42 Cervical sleeve, 3mm aperture, 60mm length, single use Cervical sleeves93/42 Cervical sleeve, 3mm aperture, 80mm length, single use Cervical sleeves93/42 Cervical sleeve, for 6.4mm tandem, 20mm length, single use Cervical sleeves93/42 Cervical sleeve, for 6.4mm tandem, 30mm length, single use Cervical sleeves93/42 Cervical sleeve, for 6.4mm tandem, 40mm length, single use Cervical sleeves93/42 Cervical sleeve, for 6.4mm tandem, 50mm single use Cervical sleeves93/42 Cervical sleeve, for 6.4mm tandem, 60mm length, single use Cervical sleeves93/42 Cervical sleeve, for 6.4mm tandem, 70mm length, single use Cervical sleeves93/42 Cervical sleeve, for 6.4mm tandem, 80mm length, single use Cervical sleeves93/42 Cervical Stop2 réf.93/42 Clamping adapter for 5 Fr bronchial catheter, BRAVOS2 réf. Clamping nut for marking screw93/42 Clamping ring for cylinders for adjustable holder93/42 Clamping screw for probe, 3 mm diameter93/42 Clamping screw of the fixation ring GM110018003 réf. Clamping screw with fixation nut for bougies Esophagus Bougie Set93/42 Clamping segment93/42 Clamping unit for endometrial applicator GM110098403 réf. Cleaning Cap, dark blue (pack of 25) Cleaning set for esophagus bougies Esophagus Bougie Set93/42 Coded transfer guide tube channel 1, for 320 mm applicators3 réf. Colpostat probe, left, CT/ MR2 réf. CT/ MR Tandem and Ovoid Set (CTO) Cylinder segment Ø 20 mm, 30 mm length93/42 Cylinder segment Ø 25 mm, 30 mm length93/42 Cylinder segment Ø 30 mm, 30 mm length93/42 Cylinder segment Ø 35 mm, 30 mm length93/42 Cylinder Segment, 40 mm diameter, 30 mm length93/42 Cylinder Ø 20 mm, 140 mm length93/42 Cylinder Ø 25 mm, 140 mm length93/42 Cylinder Ø 30 mm, 140 mm length93/42 Cylinder Ø 35 mm, 140 mm length93/42 Esophagus Bougie Set93/42 Esophagus bougie ø10 mm, with bite protector and fixation Esophagus Bougie Set93/42 Esophagus bougie ø12 mm, with bite protector and fixation Esophagus Bougie Set93/42 Esophagus bougie ø14 mm, with bite protector and fixation Esophagus Bougie Set93/42 Esophagus bougie ø8 mm, with bite protector and fixation Esophagus Bougie Set93/42 Fixation Buttons, pack of 10, sterile3 réf. Fixation for 3-channel applicators, for adjustable holder Flexible Interstitial Implant Tube Set3 réf. Front end segment 40 mm diameter, 60 mm length93/42 Front end segment Ø 20 mm, 50 mm length93/42 Front end segment Ø 25 mm, 52.5 mm length93/42 Front end segment Ø 30 mm, 55 mm length93/42 Front end segment Ø 35 mm, 57.5 mm length93/42 GammaMed adjustable Luer source guide tube Guide tube collector for up to 11 needles2 réf. Guide tube for Ø 2.0 mm needles Guided Aarhus Applicator Set3 réf. Guiding tube 60° ring for central needle Headless Screw Titanium for ovoids, (pack of 10)2 réf. Heyman Packing Applicator Set3 réf. Implant needle 100mm, diameter 1.7mm curved3 réf. Indexed Quick Connect, channel 1, reusable3 réf. Interstitial ovoid, 14.5 mm, pair, CT/ MR Interstitial ovoid pairs CT/MR (14.5‐, 20‐, 25‐, 30‐, 40- mm)3 réf. Intrauterine tandem for 45° ring, 30 mm Ring Applicator Set 45°3 réf. Intrauterine tandem for 60° ring, 30 mm Ring Applicator Set 60°3 réf. Intrauterine tandem for 90° ring, 30 mm Ring Applicator Set 90°3 réf. Intrauterine tandems (15°, 30°, 45°), CT/MR, Intrauterine needle tandem (30°) CT/MR3 réf. Leak Stop Button (pack of 50)3 réf. Leipzig-style cone ø30-45 mm, with holder and guide2 réf. Length Assessment Device Length cutting gauge for 5 Fr bronchial catheter, GammaMedplus3 réf. Length Gauge, GammaMedplus Luer Transfer Guide Tube for MammoSite Mandrin for 113 mm length3 réf. Marking screw, 0º, shielded93/42 Marking screw, 180º, shielded93/42 Marking screw, 2 x 90º, shielded93/42 Marking screw, 270º, shielded93/42 Marking screw, 90º, shielded93/42 Mini-ovoids, pair3 réf. Mould probe MR safe, 1.8 mm diameter x 320 mm, with mandrin (GM11010470) Needle box to store needles during reprocessing3 réf. Obturator, 113mm for 17 and 18 gauge needle Obturator 17G & 18G3 réf. Ovoid, 13 mm, pair, CT/ MR Ovoid pairs, CT/MR (13‐, 20‐, 25‐, 30‐, 40- mm)3 réf. Pair of Titanium colpostat tandems (left & right)3 réf. Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin (GM11010390)3 réf. Plexiglas filler piece, 90º93/42 Pushing device for implant needle, 1.7 mm diameter2 réf. Retractor, 30 mm, CT/ MR Retractor, CT/MR (30‐, 40‐ mm)2 réf. Rigid guide tube, 200 mm length93/42 Rigid guide tube, 250 mm length93/42 Shielded Applicator Set93/42 Shielded cylinder, 20 mm diameter93/42 Shielded cylinder, 23 mm diameter93/42 Shielded cylinder, 26 mm diameter93/42 Shielded cylinder, 30 mm diameter93/42 Shielded cylinder, 35 mm diameter93/42 Shielding for cone, ø 15-25mm diameter, with fixation3 réf. Source guide tube light with locking mechanism for 113 mm needles, GammaMedplus3 réf. Source guide tube with locking mechanism for 113 mm interstitial implant tube, GammaMedplus3 réf. Stainless steel needle 113mm, 17 gauge, trocar point Stainless Steel Needles 17G & 18G3 réf. Surface cone inset ø 15 mm, round3 réf. Titanium applicator probe, ø 3 mm x 320 mm, curved 15°, 30 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 15°, 40 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 15°, 50 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 15°, 60 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 15°, 70 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 15°, 80 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 30°, 30 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 30°, 40 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 30°, 50 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 30°, 60 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 30°, 70 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 30°, 80 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 45°, 30 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 45°, 40 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 45°, 50 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 45°, 60 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 45°, 70 mm93/42 Titanium applicator probe, ø 3 mm x 320 mm, curved 45°, 80 mm93/42 Titanium needle 113mm, 16 gauge (1.65mm), blunt trocar point Titanium Needles 17G3 réf. Transfer guide tube + for 200 mm catheters3 réf. Transfer guide tube + for 320 mm applicators2 réf. Transfer guide tube + of 1000 mm length for Luer connections Transfer guide tube for 113 mm applicators3 réf. Transfer guide tube for 113 mm catheters3 réf. Tube catheter, Ø 2.8 mm, GammaMedplus2 réf. Tube catheter, ø3.2mm for GammaMedplus Esophagus Bougie Set93/42 Tube catheter, ø3.2mm for VariSource 200 Esophagus Bougie Set93/42 Tube catheter, ø3.2mm, length 1500 mm, Bravos Esophagus Bougie Set93/42 Tungsten alloy shielding, 180º93/42 Tungsten alloy shielding, 90º93/42 Universal Cervix Probe Set, even lengths93/42 Universal Cervix Probe Set, odd lengths93/42 Universal Segmented Cylinder Applicator Set93/42 Universal Stump Applicator Set93/42 Varian Universal Interstitial Cylinder Set93/42 Varian Universal Interstitial Cylinder, 25mm diameter93/42 Varian Universal Interstitial Cylinder, 30mm diameter93/42 Varian Universal Interstitial Cylinder, 35mm diameter93/42 Varian Universal Interstitial Cylinder, 40mm diameter93/42 Varian Universal Multi-channel Cylinder Set93/42 Varian Universal Multi-channel Cylinder, 25mm diameter93/42 Varian Universal Multi-channel Cylinder, 30mm diameter93/42 Varian Universal Multi-channel Cylinder, 35mm diameter93/42 Varian Universal Multi-channel Cylinder, 40mm diameter93/42 Varian Universal Titanium Cervix Probe Set, even lengths93/42 Varian Universal Titanium Cervix Probe Set, odd lengths93/42 X-ray marker BV set I, up to 200 mm needles, coded 01-063 réf. ClickFit transfer guide tube with integrated channel 1 Quick Connect3 réf. (plus commercialisé) Luer Transfer Guide Tube Set, Channels Numbered 1-203 réf. (plus commercialisé) Needle Click Fit Transfer Guide Tube Set, Channels Numbered 1-103 réf. (plus commercialisé)	I, IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Cryosurgery equipment	Z120102	1.7 mm Long Shaft RenalCryo™ Cryoprobe3 réf. 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal3 réf. 2.4mm V-Probe™ Cryoprobe3 réf. 3.8 mm Long Shaft RenalCryo™ Cryoprobe3 réf. 8mm Cryoprobe2 réf. 3 autres Cryocare Touch System Prostate Procedure Probe Pack DP35-0595-1083 réf. TempProbe™ Device	IIa, IIb MDR	Fiche EUDAMED Signaler une erreur
Radiotherapy treatment planning systems	Z11010401	ARIA Radiation Therapy Management3 réf. ARIA Radiation Therapy Management 15.693/42 Eclipse Neo Treatment Planning3 réf. Eclipse Treatment Planning System3 réf. Varian Treatment	IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Radiotherapy treatment planning instruments - software accessories	Z11010482	Eclipse Treatment Planning System 15.693/42 Mobius3D VariSeed 10.0 Vitesse 5.0 Vitesee	IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Linear accelerators - other	Z11010199	Electron Applicator Mount3 réf. High Dose Total Skin Electron Mount 6MeV2 réf. VARIAN APPL MLC 10X10CM,65.43 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Radiosurgery instruments - hardware accessories	Z11010780	Cranial Screws, Long, Pouch of 23 réf. HeadFrame Wrench Integrated Conical Collimator Verification and Interlock System (ICVI) Conical Collimator Set2 réf.	I, IIa, IIb MDR	Fiche EUDAMED Signaler une erreur
Brachytherapy radiation systems	Z11010301	Afterloader Basic Device GammaMedplus 115 Volt, Series iX GammaMedplus iX / GammaMedplus 3/24 iX3 réf. BRAVOS Afterloader System 1.2 MR12 réf.	IIb MDR	Fiche EUDAMED Signaler une erreur
Electrosurgery instruments - hardware accessories	Z12010980	IntelliBlate Ximitry Probe Assembly, 13G x 15cm3 réf. Temperature Sensor Probe, 18G x 20cm	IIa, IIb MDR	Fiche EUDAMED Signaler une erreur
Linear accelerators - hardware accessories	Z11010180	Compensator Assembly, 20cm/30cm3 réf. Conical Collimator Mount3 réf.	I, IIb MDR	Fiche EUDAMED Signaler une erreur
Multi and high energy linear accelerators	Z11010103	Accela3 réf. EDGE EDGE 4.03 réf.	IIb MDR	Fiche EUDAMED Signaler une erreur
Picture archiving and communication systems	Z110603	Velocity2 réf. Velocity Medical Imaging Data Comparison Software93/42	IIa, IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Various bioimaging and radiotherapy instruments - other	Z119099	IDENTIFY3 réf. Respiratory Gating for Scanners2 réf.	IIb MDR	Fiche EUDAMED Signaler une erreur
Electrosurgical units (ESU) for general use	Z12010902	IntelliBlate Microwave Ablation System Console	IIb MDR	Fiche EUDAMED Signaler une erreur
General medicine therapeutic treatment instruments - software accessories	Z12040282	Noona Mobile Service6 réf.	I, IIa MDR	Fiche EUDAMED Signaler une erreur
Linear accelerators - software accessories	Z11010182	Varian Verification System	IIb MDR	Fiche EUDAMED Signaler une erreur
Radiotherapy treatment planning instruments - medical device software	Z11010492	Eclipse Neo Treatment Management3 réf.	IIb MDR	Fiche EUDAMED Signaler une erreur
Single energy linear accelerators	Z11010101	Ethos Radiotherapy System3 réf.	IIb MDR	Fiche EUDAMED Signaler une erreur
Various bioimaging and radiotherapy instruments - hardware accessories	Z119080	Gating Reflector Block3 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Various radiotherapy and radiosurgery instruments - hardware accessories	Z11019080	Visual Coaching Device	I MDR	Fiche EUDAMED Signaler une erreur

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