Manufacturer

Varian Medical Systems

United StatesLegal entities : Varian Medical Systems, Inc.

Markets : Belgium · Finland · France · Germany · Netherlands · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 206 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : France 36 · Germany 6 · Finland 2 · Belgium 1

EU representative : Siemens Healthineers Nederland B.V. (Netherlands)

19 categories, 227 models including 224 on the market, 1 country

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
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Category	EMDN code	Registered models	Class	Contact
Brachytherapy radiation systems - hardware accessories	Z11010380	3D Interstitial Ring Applicator Set 60°3 refs 3D Interstitial Ring Applicator Set 90°3 refs 3D-FSD interstitial ovoid pair for 20 mm spread, with 4 needle guide holes each ovoid3 refs Aarhus Applicator Set3 refs Adapter pin for GYN templates3 refs 180 others Advanced Breast Template System3 refs Allen key, 2.0 mm wrench size Allen Wrench 2mm3 refs Applicator and Dilator for Proctoscope ø26 mm3 refs 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 refs Bite protector for intraluminal applicators3 refs 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 refs Bracket for ring applicator for flexible fixation GYN3 refs Catheter Surface Flap Applicator Set2 refs Catheter Transfer Guide Tube Set, Channels Numbered 1-103 refs Central fixation screw for intrauterine probe GM110009803 refs Cervical sleeve IU ø6.4mm, 30mm, with marker3 refs 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 refs93/42 Clamping adapter for 5 Fr bronchial catheter, BRAVOS2 refs 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 refs Clamping screw with fixation nut for bougies Esophagus Bougie Set93/42 Clamping segment93/42 Clamping unit for endometrial applicator GM110098403 refs 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 refs Colpostat probe, left, CT/ MR2 refs 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 refs Fixation for 3-channel applicators, for adjustable holder Flexible Interstitial Implant Tube Set3 refs 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 refs Guide tube for Ø 2.0 mm needles Guided Aarhus Applicator Set3 refs Guiding tube 60° ring for central needle Headless Screw Titanium for ovoids, (pack of 10)2 refs Heyman Packing Applicator Set3 refs Implant needle 100mm, diameter 1.7mm curved3 refs Indexed Quick Connect, channel 1, reusable3 refs Interstitial ovoid, 14.5 mm, pair, CT/ MR Interstitial ovoid pairs CT/MR (14.5‐, 20‐, 25‐, 30‐, 40- mm)3 refs Intrauterine tandem for 45° ring, 30 mm Ring Applicator Set 45°3 refs Intrauterine tandem for 60° ring, 30 mm Ring Applicator Set 60°3 refs Intrauterine tandem for 90° ring, 30 mm Ring Applicator Set 90°3 refs Intrauterine tandems (15°, 30°, 45°), CT/MR, Intrauterine needle tandem (30°) CT/MR3 refs Leak Stop Button (pack of 50)3 refs Leipzig-style cone ø30-45 mm, with holder and guide2 refs Length Assessment Device Length cutting gauge for 5 Fr bronchial catheter, GammaMedplus3 refs Length Gauge, GammaMedplus Luer Transfer Guide Tube for MammoSite Mandrin for 113 mm length3 refs 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 refs Mould probe MR safe, 1.8 mm diameter x 320 mm, with mandrin (GM11010470) Needle box to store needles during reprocessing3 refs Obturator, 113mm for 17 and 18 gauge needle Obturator 17G & 18G3 refs Ovoid, 13 mm, pair, CT/ MR Ovoid pairs, CT/MR (13‐, 20‐, 25‐, 30‐, 40- mm)3 refs Pair of Titanium colpostat tandems (left & right)3 refs Plastic needle MR safe, 2.0 mm diameter x 113 mm length, with mandrin (GM11010390)3 refs Plexiglas filler piece, 90º93/42 Pushing device for implant needle, 1.7 mm diameter2 refs Retractor, 30 mm, CT/ MR Retractor, CT/MR (30‐, 40‐ mm)2 refs 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 refs Source guide tube light with locking mechanism for 113 mm needles, GammaMedplus3 refs Source guide tube with locking mechanism for 113 mm interstitial implant tube, GammaMedplus3 refs Stainless steel needle 113mm, 17 gauge, trocar point Stainless Steel Needles 17G & 18G3 refs Surface cone inset ø 15 mm, round3 refs 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 refs Transfer guide tube + for 200 mm catheters3 refs Transfer guide tube + for 320 mm applicators2 refs Transfer guide tube + of 1000 mm length for Luer connections Transfer guide tube for 113 mm applicators3 refs Transfer guide tube for 113 mm catheters3 refs Tube catheter, Ø 2.8 mm, GammaMedplus2 refs 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 refs ClickFit transfer guide tube with integrated channel 1 Quick Connect3 refs (no longer marketed) Luer Transfer Guide Tube Set, Channels Numbered 1-203 refs (no longer marketed) Needle Click Fit Transfer Guide Tube Set, Channels Numbered 1-103 refs (no longer marketed)	I, IIa MDR, 93/42	EUDAMED record Report an error
Cryosurgery equipment	Z120102	1.7 mm Long Shaft RenalCryo™ Cryoprobe3 refs 2.1mm (14 G) ISOLIS Cryoprobe, 15cm Length, Ellipsoidal3 refs 2.4mm V-Probe™ Cryoprobe3 refs 3.8 mm Long Shaft RenalCryo™ Cryoprobe3 refs 8mm Cryoprobe2 refs 3 others Cryocare Touch System Prostate Procedure Probe Pack DP35-0595-1083 refs TempProbe™ Device	IIa, IIb MDR	EUDAMED record Report an error
Radiotherapy treatment planning systems	Z11010401	ARIA Radiation Therapy Management3 refs ARIA Radiation Therapy Management 15.693/42 Eclipse Neo Treatment Planning3 refs Eclipse Treatment Planning System3 refs Varian Treatment	IIb MDR, 93/42	EUDAMED record Report an error
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	EUDAMED record Report an error
Linear accelerators - other	Z11010199	Electron Applicator Mount3 refs High Dose Total Skin Electron Mount 6MeV2 refs VARIAN APPL MLC 10X10CM,65.43 refs	I MDR	EUDAMED record Report an error
Radiosurgery instruments - hardware accessories	Z11010780	Cranial Screws, Long, Pouch of 23 refs HeadFrame Wrench Integrated Conical Collimator Verification and Interlock System (ICVI) Conical Collimator Set2 refs	I, IIa, IIb MDR	EUDAMED record Report an error
Brachytherapy radiation systems	Z11010301	Afterloader Basic Device GammaMedplus 115 Volt, Series iX GammaMedplus iX / GammaMedplus 3/24 iX3 refs BRAVOS Afterloader System 1.2 MR12 refs	IIb MDR	EUDAMED record Report an error
Electrosurgery instruments - hardware accessories	Z12010980	IntelliBlate Ximitry Probe Assembly, 13G x 15cm3 refs Temperature Sensor Probe, 18G x 20cm	IIa, IIb MDR	EUDAMED record Report an error
Linear accelerators - hardware accessories	Z11010180	Compensator Assembly, 20cm/30cm3 refs Conical Collimator Mount3 refs	I, IIb MDR	EUDAMED record Report an error
Multi and high energy linear accelerators	Z11010103	Accela3 refs EDGE EDGE 4.03 refs	IIb MDR	EUDAMED record Report an error
Picture archiving and communication systems	Z110603	Velocity2 refs Velocity Medical Imaging Data Comparison Software93/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - other	Z119099	IDENTIFY3 refs Respiratory Gating for Scanners2 refs	IIb MDR	EUDAMED record Report an error
Electrosurgical units (ESU) for general use	Z12010902	IntelliBlate Microwave Ablation System Console	IIb MDR	EUDAMED record Report an error
General medicine therapeutic treatment instruments - software accessories	Z12040282	Noona Mobile Service6 refs	I, IIa MDR	EUDAMED record Report an error
Linear accelerators - software accessories	Z11010182	Varian Verification System	IIb MDR	EUDAMED record Report an error
Radiotherapy treatment planning instruments - medical device software	Z11010492	Eclipse Neo Treatment Management3 refs	IIb MDR	EUDAMED record Report an error
Single energy linear accelerators	Z11010101	Ethos Radiotherapy System3 refs	IIb MDR	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - hardware accessories	Z119080	Gating Reflector Block3 refs	I MDR	EUDAMED record Report an error
Various radiotherapy and radiosurgery instruments - hardware accessories	Z11019080	Visual Coaching Device	I MDR	EUDAMED record Report an error

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