Fabricant

Brainlab

Allemagne, IsraëlEntités : Brainlab Ltd., Brainlab SE

Premiers pays de mise sur le marché déclarés dans EUDAMED : Allemagne, Belgique

Marchés publics remportés : France 13, Allemagne 36, Espagne 15, Pologne 14, Autriche 8, Italie 4, Suède 4, Belgique 3, Portugal 3, Finlande 2, Pays-Bas 2, Danemark 1

Mandataire UE : AR Experts B.V. (Pays-Bas)

Site web regulatory.affairs@brainlab.com

18 catégories, 193 modèles dont 184 en vente, 2 pays

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Plus commercialisé
93/42 Ancienne directive, pas encore certifié selon le règlement MDR
Cliquez sur une catégorie pour voir les concurrents, sur un modèle pour ouvrir sa fiche EUDAMED.

Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Surgical navigation instruments - hardware accessories	Z12011480	ADAPTER FOR SURGICAL MOTOR SYSTEM ADAPTER LONG FOR PATIENT REFERENCE CLAMP2 réf. ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY 52419A ADHESIVE REFLECTIVE FLAT MARKERS (10 PCS) 4056481AdFlatMarker2T Alignment Arm2 réf. 106 autres Alignment Bone Anchor Cranial 2.1/3.8 Alignment Depth Control Spine Alignment Guide Tube Cranial 2.5/7.53 réf. Alignment Reduction Tube Cranial 2.5/4.0 Alignment Trocar Spine 2.43 réf. AUTO-REG MATRIX iMRI2 réf. AWL (3,0 MM) FOR OPEN SURGERY3 réf. Bone Fixator "1-Pin", X-Press Size-L Spine & Trauma 3D Instruments93/42 Bone Fixator "1-Pin", X-Press Size-M Spine & Trauma 3D Instruments93/42 Bone Fixator "1-Pin", X-Press Size-S Spine & Trauma 3D Instruments93/42 BONE FIXATOR 2-PIN X-PRESS Buzz Navigation (Ceiling-Mounted) C-ARM ADAPTER FOR GE OEC 3D LEFT3 réf. CALIBRATION PHANTOM INTRAOPERATIVE CT2 réf. Cirq Arm System 2.0 Cirq Instrument Holder Cirq Instrument Holder Module Cirq Robotic Alignment Module CIRQ ROBOTIC BIOPSY BONE ANCHOR CRANIAL93/42 CIRQ ROBOTIC BIOPSY GUIDE TUBE CRANIAL93/42 Cirq Robotic Depth Tracking Array beige2 réf. Cirq Robotic Instrument Holder Cranial2 réf. Cirq Robotic Tracking Array 10.03 réf. Curve Navigation Curve Navigation 17700 DISP FIXATION PIN 4.0 X 125 MM (10 PCS) DOUBLE OPEN-END WRENCH (10 X 14 MM) Drill Guide Tube (4.5 mm) 51839-453 réf. DRILL DEPTH STOP CRANIAL 2.53 réf. Drill Guide Handle 518393 réf. Drill Guide Compact Handle 4 Markers3 réf. Drill Guide Tissue Protection Sleeve 10mm Spine & Trauma 3D Instruments93/42 Drill Guide Trocar Tube 5mm X 180mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 2.4 X 150mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 2.6mm X 150mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 2.6mm X 200mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 3.0 X 150 mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 3.2mm X 150mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 3.2mm X 200mm Spine & Trauma 3D Instruments93/42 Drill Guide Tube 4.5mm X 200mm Spine & Trauma 3D Instruments93/42 EM Instrument Tracker EM Patient Reference EM Pointer2 réf. EM Registration Pointer Eraser Pointer Tip (Curved)93/42 Eraser Pointer Tip (Straight)93/42 Gauge for Softouch Registration Pointer GUIDE TUBE PEDICLE ACCESS NEEDLE (1.8 MM) HANDHELD REGISTRATION DEVICE FLUORO 2D Spine & Trauma 3D Instruments93/42 HANDLE FOR MULTIPLE TIP POINTER HANDLE GEARSHIFT FOR OPEN SURGERY2 réf. HEX SCREW-DRIVER 2.5 MM HEX SCREWDRIVER BALL-END (2.5 MM)3 réf. INSTRUMENT ADAPTER CLAMP STARLINK FOR CYLINDRICAL INSTRUMENTS3 réf. INSTRUMENT CALIBRATION MATRIX 41874B INSTRUMENT TRACKING ARRAY S&T (SIZE L)3 réf. INSTRUMENT TRACKING ARRAY STARLINK SIZE L3 réf. Kick 2 Navigation Station EM, Kick® Navigation, Kick2® Navigation, Kick Navigation EM, Kick Navigation System EM2 réf. MICROSCOPE ADAPTER FOR TRACKING ARRAY (LEICA)2 réf. MICROSCOPE TRACKING ARRAY Pat. Ref. Array for Skull Clamp3 réf. PATIENT REFERENCE ARRAY FOR DISPOSABLE HEADBAND PATIENT REFERENCE ARRAY SPINE & TRAUMA3 réf. PATIENT REFERENCE ROD-CLAMP SPINE & TRAUMA3 réf. Pointer Sharp-Tip-Extended Spine & Trauma 3D Instruments93/42 Pointer Tip (Offset 0°, length 100 mm)93/42 Pointer Tip (Offset 0°, length 150 mm)93/42 Pointer Tip (Offset 0°, length 60 mm)93/42 Pointer Tip (Offset 30°, length 95 mm)93/42 Pointer, Blunt Tip93/42 Quip Instrument Adapter 45° Angled 582103 réf. Quip Link Instrument Tracking Array For 3 Marker Spheres L 581933 réf. RADIOLUCENT DRAPELINK BASE SHORT3 réf. RADIOLUCENT DRAPELINK PATIENT REFERENCE ARRAY REFLECTIVE DISKS FLUORO KIT REV2-21 PCS REGISTRATION MATRIX FOR IMRI HEAD HOLDER (NORAS) Skull Reference Array Skull Reference Base2 réf. Skull Reference Screwdriver Blade2 réf. SOFTOUCH POINTER (REV 3)93/42 Spine Reference Array (4-Marker) Spine & Trauma 3D Instruments93/42 SPINE REFERENCE CLAMP (CARBON) Spine & Trauma 3D Instruments93/42 Suction MS (CH10) Starlink Frazier93/42 Suction MS (CH8) Starlink93/42 Suction MS (CH8) Starlink Frazier93/42 Suction STD (CH10) Starlink93/42 Suction STD (CH10) Starlink Frazier93/42 Suction STD (CH8) Starlink93/42 Suction STD (CH8) Starlink Frazier93/42 Trocar Insert 5mm93/42 Trocar Reduction Sleeve 2.0mm Spine & Trauma 3D Instruments93/42 Trocar Reduction Sleeve 2.8mm Spine & Trauma 3D Instruments93/42 Trocar Reduction Sleeve 3.2mm Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 2.4 mm Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 2.6 mm Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 2.6mm (200mm) Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 3.2 mm Spine & Trauma 3D Instruments93/42 Trocar Sharp Tip 3.2mm (200mm) Spine & Trauma 3D Instruments93/42 ULTRASOUND NAVIGATION ADAPTER (ALOKA C42K) 41860-423 réf. ULTRASOUND REGISTRATION PHANTOM V-Inset GE Headholder Kit3 réf. Varioguide Array 4-Marker3 réf. Z-touch Laser Registration Pointer Z-Touch Rev293/42 Registration Matrix CT – Minimally Invasive (Cranial and Spine)93/42 (plus commercialisé) Registration Matrix CT – Open Surgery (Spine)93/42 (plus commercialisé) Registration Matrix CT – Small Incision (Spine)93/42 (plus commercialisé)	I, IIa, IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Various digital bioimaging management instruments - medical device software	Z11069092	Brainlab Elements - Guide XT, 3.093/42 Brainlab Elements - Trajectory Planning, 2.593/42 Brainlab Elements BOLD MRI Mapping, 1.0 Brainlab Elements Contouring, 4.03 réf. Brainlab Elements Fibertracking, 2.02 réf. 10 autres Brainlab Elements Image Fusion Angio, 1.0 Brainlab Elements Image Fusion, 4.03 réf. Brainlab Elements – Trajectory Planning, 2.6 Brainlab Elements, 7.1 Origin Edge Software Image, 1.0 Quentry, 3.2 Spine Planning 3.02 réf. Spine Planning, 1.093/42 Viewer, 5.23 réf. Elements Viewer3 réf.93/42 (plus commercialisé)	I, IIa, IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Surgical navigation instruments - medical device software	Z12011492	Alignment Software Cranial, 2.02 réf. Cranial EM, 1.193/42 Cranial Navigation System Navigation, 4.093/42 Cranial Navigation System Registration, 3.593/42 Cranial Navigation, 4.12 réf. 8 autres Cranial/ENT, 3.193/42 ENT EM, 1.293/42 Fluoro 3D, 1.093/42 Instrument Selection, 1.593/42 Registration Software Paired Point, 3.593/42 Registration Software Spine Surface Matching, 1.093/42 Spine & Trauma 3D Navigation, 1.593/42 Spine & Trauma Navigation, 2.03 réf.	IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Surgical navigation instruments - consumables	Z12011485	Cirq Robotic Disposable Kinematic Unit Disposable Clip-on Remote Control (1 pcs.)2 réf. DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS) 41860-463 réf. DISPOSABLE HEADBAND FOR PATIENT REFERENCE ARRAY (1 PC) DISPOSABLE HEADBAND FOR PATIENT REFERENCE ARRAY (10 PCS)2 réf. Disposable Radiolucent Skull Pins (3 Pcs)93/42 7 autres Disposable Radiolucent Skull Pins (30 Pcs)93/42 Disposable Reflective Marker Spheres (3pcs)2 réf. Disposable Skull Reference Bone Fixation Screw 1.5 mm x 6 mm Disposable Skull Reference Drill Bit 1.1 mm for Bone Fixation Screw Disposable Trocar Insert Pedicle Access Needle (1 PC) Drill Bit Cranial 2.1/2.53 réf. EM Disposable Stylet	I, IIa, III MDR, 93/42	Fiche EUDAMED Signaler une erreur
Surgical navigation instruments - software accessories	Z12011482	Alignment Software Spine, 2.02 réf. Automatic Registration iMRI, 1.13 réf. Automatic Registration, 2.593/42 Cranial IGS System Ultrasound Navigation, 1.193/42 Microscope Navigation, 1.693/42 5 autres Microscope Navigation, 1.7 Mixed Reality Spine Navigation, 1.02 réf. Registration Fluoro 3D, 1.5 Ultrasound Navigation, 1.2 Cranial IGS System Automatic Registration iMRI, 1.093/42 (plus commercialisé)	IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Radiotherapy treatment planning instruments - medical device software	Z11010492	RT Elements - Cranial SRS w/ Cones, 3.093/42 RT Elements - Cranial SRS, 3.093/42 RT Elements - Dose Review, 3.093/42 RT Elements - Multiple Brain Mets SRS, 3.093/42 RT Elements - RT QA, 3.093/42 2 autres RT Elements - Spine SRS, 3.093/42 RT Elements, 4.03 réf.	IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Various radiotherapy and radiosurgery instruments - hardware accessories	Z11019080	Cranial 4PI Basic Mask (1 Pc) Cranial 4Pi Masks3 réf. Cranial 4PI CT Overlay Cranial 4Pi Overlays3 réf. Cranial 4PI Head Support Standard Cranial 4PI Headrest Inlays3 réf. Cranial 4PI Headrest Low-Neck Cranial 4Pi Headrests3 réf. Cranial 4PI Spacer 20mm Cranial 4Pi Wedges and Spacers3 réf. 2 autres Frameless SRS CARBON BASE3 réf. Patient Mask Set (plus commercialisé)	I MDR	Fiche EUDAMED Signaler une erreur
Various digital bioimaging management instruments - software accessories	Z11069082	Brainlab Origin OR, 1.0 Buzz Virtual App, 1.1 DICOM Proxy, 4.3 Origin Data Management, 3.12 réf.	I, IIa MDR	Fiche EUDAMED Signaler une erreur
Various digital bioimaging management instruments - hardware accessories	Z11069080	Buzz O.R. Compute Quip Quip Eye	I MDR	Fiche EUDAMED Signaler une erreur
Stereotactic neurosurgery instruments - consumables	Z12100685	Disposable Pre-calibrated Suction Charr. 82 réf. Disposable stylet	III MDR	Fiche EUDAMED Signaler une erreur
Bioimaging viewing monitors	Z11900802	Wall Touch Screen	I MDR	Fiche EUDAMED Signaler une erreur
Digital angiography systems - medical device software	Z11030192	Vascular Navigation PAD, 2.0	IIb MDR	Fiche EUDAMED Signaler une erreur
Motorised orthopaedic surgery system instruments - hardware accessories	Z12130580	DRILL BIT 2.0 MM DEPTH CONTROL 0-60 MM3 réf.	IIa MDR	Fiche EUDAMED Signaler une erreur
Various orthopaedic and traumatology instruments - hardware accessories	Z12139080	KingMark Calibration Device2 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Various orthopaedic and traumatology instruments - software accessories	Z12139082	TraumaCad3 réf.	IIa MDR	Fiche EUDAMED Signaler une erreur
Various radiotherapy and radiosurgery instruments - other	Z11019099	ExacTrac Dynamic, 1.13 réf.	IIb MDR	Fiche EUDAMED Signaler une erreur
Stereotactic orthopaedic surgery instruments - hardware accessories Aucun modèle encore en vente	Z12130480	Hip Pointer Gauge (plus commercialisé) Pinless Femur Reference Array (plus commercialisé)	I MDR	Fiche EUDAMED Signaler une erreur
Cleaning, disinfection and sterilisation instruments - hardware accessories Aucun modèle encore en vente	Z12011380	Sterilization Tray Adjustable Cutting Block3 réf. (plus commercialisé)	I MDR	Fiche EUDAMED Signaler une erreur

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