Manufacturer

Brainlab

Germany, IsraelLegal entities : Brainlab Ltd., Brainlab SE

Markets : Austria · Belgium · Denmark · Finland · France · Germany · Italy · Netherlands · Poland · Portugal · Spain · Sweden · United States

Approvals : EU – class I, IIa, IIb, III · United States (FDA) – 510(k) : 145 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : Germany 36 · Spain 15 · Poland 14 · France 13 · Austria 8 · Italy 4 · Sweden 4 · Belgium 3 · Portugal 3 · Finland 2 · Netherlands 2 · Denmark 1

EU representative : AR Experts B.V. (Netherlands)

Website regulatory.affairs@brainlab.com

18 categories, 193 models including 184 on the market, 2 countries

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On the market
No longer marketed
93/42 Former directive, not yet certified under the MDR
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Surgical navigation instruments - hardware accessories	Z12011480	ADAPTER FOR SURGICAL MOTOR SYSTEM ADAPTER LONG FOR PATIENT REFERENCE CLAMP2 refs ADAPTER X-PRESS FOR PATIENT REFERENCE ARRAY 52419A ADHESIVE REFLECTIVE FLAT MARKERS (10 PCS) 4056481AdFlatMarker2T Alignment Arm2 refs 106 others Alignment Bone Anchor Cranial 2.1/3.8 Alignment Depth Control Spine Alignment Guide Tube Cranial 2.5/7.53 refs Alignment Reduction Tube Cranial 2.5/4.0 Alignment Trocar Spine 2.43 refs AUTO-REG MATRIX iMRI2 refs AWL (3,0 MM) FOR OPEN SURGERY3 refs 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 refs CALIBRATION PHANTOM INTRAOPERATIVE CT2 refs 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 refs Cirq Robotic Instrument Holder Cranial2 refs Cirq Robotic Tracking Array 10.03 refs 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 refs DRILL DEPTH STOP CRANIAL 2.53 refs Drill Guide Handle 518393 refs Drill Guide Compact Handle 4 Markers3 refs 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 refs 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 refs HEX SCREW-DRIVER 2.5 MM HEX SCREWDRIVER BALL-END (2.5 MM)3 refs INSTRUMENT ADAPTER CLAMP STARLINK FOR CYLINDRICAL INSTRUMENTS3 refs INSTRUMENT CALIBRATION MATRIX 41874B INSTRUMENT TRACKING ARRAY S&T (SIZE L)3 refs INSTRUMENT TRACKING ARRAY STARLINK SIZE L3 refs Kick 2 Navigation Station EM, Kick® Navigation, Kick2® Navigation, Kick Navigation EM, Kick Navigation System EM2 refs MICROSCOPE ADAPTER FOR TRACKING ARRAY (LEICA)2 refs MICROSCOPE TRACKING ARRAY Pat. Ref. Array for Skull Clamp3 refs PATIENT REFERENCE ARRAY FOR DISPOSABLE HEADBAND PATIENT REFERENCE ARRAY SPINE & TRAUMA3 refs PATIENT REFERENCE ROD-CLAMP SPINE & TRAUMA3 refs 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 refs Quip Link Instrument Tracking Array For 3 Marker Spheres L 581933 refs RADIOLUCENT DRAPELINK BASE SHORT3 refs 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 refs Skull Reference Screwdriver Blade2 refs 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 refs ULTRASOUND REGISTRATION PHANTOM V-Inset GE Headholder Kit3 refs Varioguide Array 4-Marker3 refs Z-touch Laser Registration Pointer Z-Touch Rev293/42 Registration Matrix CT – Minimally Invasive (Cranial and Spine)93/42 (no longer marketed) Registration Matrix CT – Open Surgery (Spine)93/42 (no longer marketed) Registration Matrix CT – Small Incision (Spine)93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
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 refs Brainlab Elements Fibertracking, 2.02 refs 10 others Brainlab Elements Image Fusion Angio, 1.0 Brainlab Elements Image Fusion, 4.03 refs Brainlab Elements – Trajectory Planning, 2.6 Brainlab Elements, 7.1 Origin Edge Software Image, 1.0 Quentry, 3.2 Spine Planning 3.02 refs Spine Planning, 1.093/42 Viewer, 5.23 refs Elements Viewer3 refs93/42 (no longer marketed)	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Surgical navigation instruments - medical device software	Z12011492	Alignment Software Cranial, 2.02 refs Cranial EM, 1.193/42 Cranial Navigation System Navigation, 4.093/42 Cranial Navigation System Registration, 3.593/42 Cranial Navigation, 4.12 refs 8 others 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 refs	IIb MDR, 93/42	EUDAMED record Report an error
Surgical navigation instruments - consumables	Z12011485	Cirq Robotic Disposable Kinematic Unit Disposable Clip-on Remote Control (1 pcs.)2 refs DISPOSABLE GENERIC ULTRASOUND ADAPTER BAND (SIZE L) (3 PCS) 41860-463 refs DISPOSABLE HEADBAND FOR PATIENT REFERENCE ARRAY (1 PC) DISPOSABLE HEADBAND FOR PATIENT REFERENCE ARRAY (10 PCS)2 refs Disposable Radiolucent Skull Pins (3 Pcs)93/42 7 others Disposable Radiolucent Skull Pins (30 Pcs)93/42 Disposable Reflective Marker Spheres (3pcs)2 refs 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 refs EM Disposable Stylet	I, IIa, III MDR, 93/42	EUDAMED record Report an error
Surgical navigation instruments - software accessories	Z12011482	Alignment Software Spine, 2.02 refs Automatic Registration iMRI, 1.13 refs Automatic Registration, 2.593/42 Cranial IGS System Ultrasound Navigation, 1.193/42 Microscope Navigation, 1.693/42 5 others Microscope Navigation, 1.7 Mixed Reality Spine Navigation, 1.02 refs Registration Fluoro 3D, 1.5 Ultrasound Navigation, 1.2 Cranial IGS System Automatic Registration iMRI, 1.093/42 (no longer marketed)	IIb MDR, 93/42	EUDAMED record Report an error
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 others RT Elements - Spine SRS, 3.093/42 RT Elements, 4.03 refs	IIb MDR, 93/42	EUDAMED record Report an error
Various radiotherapy and radiosurgery instruments - hardware accessories	Z11019080	Cranial 4PI Basic Mask (1 Pc) Cranial 4Pi Masks3 refs Cranial 4PI CT Overlay Cranial 4Pi Overlays3 refs Cranial 4PI Head Support Standard Cranial 4PI Headrest Inlays3 refs Cranial 4PI Headrest Low-Neck Cranial 4Pi Headrests3 refs Cranial 4PI Spacer 20mm Cranial 4Pi Wedges and Spacers3 refs 2 others Frameless SRS CARBON BASE3 refs Patient Mask Set (no longer marketed)	I MDR	EUDAMED record Report an error
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 refs	I, IIa MDR	EUDAMED record Report an error
Various digital bioimaging management instruments - hardware accessories	Z11069080	Buzz O.R. Compute Quip Quip Eye	I MDR	EUDAMED record Report an error
Stereotactic neurosurgery instruments - consumables	Z12100685	Disposable Pre-calibrated Suction Charr. 82 refs Disposable stylet	III MDR	EUDAMED record Report an error
Bioimaging viewing monitors	Z11900802	Wall Touch Screen	I MDR	EUDAMED record Report an error
Digital angiography systems - medical device software	Z11030192	Vascular Navigation PAD, 2.0	IIb MDR	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - hardware accessories	Z12130580	DRILL BIT 2.0 MM DEPTH CONTROL 0-60 MM3 refs	IIa MDR	EUDAMED record Report an error
Various orthopaedic and traumatology instruments - hardware accessories	Z12139080	KingMark Calibration Device2 refs	I MDR	EUDAMED record Report an error
Various orthopaedic and traumatology instruments - software accessories	Z12139082	TraumaCad3 refs	IIa MDR	EUDAMED record Report an error
Various radiotherapy and radiosurgery instruments - other	Z11019099	ExacTrac Dynamic, 1.13 refs	IIb MDR	EUDAMED record Report an error
Stereotactic orthopaedic surgery instruments - hardware accessories No model still on the market	Z12130480	Hip Pointer Gauge (no longer marketed) Pinless Femur Reference Array (no longer marketed)	I MDR	EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - hardware accessories No model still on the market	Z12011380	Sterilization Tray Adjustable Cutting Block3 refs (no longer marketed)	I MDR	EUDAMED record Report an error

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