Manufacturer

Aesculap

GermanyLegal entities : Aesculap AG

Markets : Germany · Poland · United States

Approvals : EU – class I, IIa, IIb, III · United States (FDA) – 510(k) : 223 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : Poland 14 · Germany 2

Website eudamed@bbraun.com

40 categories, 106 models including 106 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
Click a category to see competitors, a model to open its EUDAMED record.

Category	EMDN code	Registered models	Class	Contact
Instruments for motorised neurosurgery systems - hardware accessories	Z12100980	ACCULAN 4 ELAN 4 shaft for reciprocating saw2 refs ACCULAN 4 ELAN 4/Acculan saw blade (RU)3 refs ACCULAN 4 ELAN 4/Acculan saw blade (SU)3 refs ACTIV C3 refs Aesculap14 refs 17 others ELAN 4 2.35 rotating instrument3 refs ELAN 4 craniotome attachment ELAN 4 electro trepanation motor ELAN 4 highspeed handpiece attachment3 refs ELAN 4 lateral burr guard ELAN 4 MIS handpiece shaft3 refs ELAN 4 MIS rotating instrument (SU)3 refs ELAN 4 rotating instrument (RU)3 refs ELAN 4 rotating instrument (SU)3 refs ELAN 4 rotating instrument for metal2 refs ELAN 4 saw blade (RU)3 refs ELAN 4 saw blade (SU)3 refs ELAN 4 shaft for transversal saw3 refs ELAN 4 spray nozzle with holding clips2 refs ELAN 4 spray nozzle with ring fixation3 refs HI-LINE7 refs HI-LINE XS6 refs	IIa MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - hardware accessories	Z12019080	ACCULAN Aesculap10 refs ELAN 4 cleaning device2 refs ELAN 4 electro - 2.35 handpiece ELAN 4 electro control unit 15 others ELAN 4 electro craniotome ELAN 4 electro foot control ELAN 4 electro highspeed handpiece3 refs ELAN 4 electro micro reciprocating saw ELAN 4 electro micro sagittal saw ELAN 4 electro MIS handpiece ELAN 4 electro motor cable f/foot ctrl ELAN 4 electro motor cable w/hand ctrl2 refs ELAN 4 electro reciprocating saw ELAN 4 electro sagittal saw ELAN 4 electro transversal saw ELAN 4 electro wireless foot control ELAN 4 elektro motor intra ELAN 4 rinsing adaptor2 refs UNITRAC®	I, IIa MDR	EUDAMED record Report an error
Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images	Z12020401	Aesculap 2D Camera control unit Aesculap EDDY 3D documentation system EINSTEINVISION 3.0 3D Camera control unit EINSTEINVISION 3.0 3D Camera head2 refs SMARTVUE 2D Camera head2 refs	I, IIa MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - hardware accessories	Z12029080	Aesculap93/42 M-TRAC®4 refs MINOP® InVent UNITRAC®	I, IIa MDR, 93/42	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - consumables	Z12019085	Aesculap93/42 KAIRISON SUSI®11 refs UNITRAC®	I, IIa MDR, 93/42	EUDAMED record Report an error
Irrigators	Z12019007	Aesculap MINOP® TREND3 refs MULTIFLOW PLUS93/42	I, IIa, IIb MDR, 93/42	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - hardware accessories	Z12130580	ACCULAN 3TI4 refs ACCULAN II Aesculap4 refs	IIa MDR	EUDAMED record Report an error
Surgical cameras	Z12020405	Aesculap EINSTEINVISION 3.0 FI 3D FI Camera control unit EINSTEINVISION 3.0 FI 3D FI camera head2 refs	I, IIa MDR	EUDAMED record Report an error
Surgical navigation instruments - hardware accessories	Z12011480	ORTHOPILOT8 refs ORTHOPILOT 44 refs ORTHOPILOT THA8 refs	I, IIa MDR	EUDAMED record Report an error
Surgical navigation instruments - software accessories	Z12011482	ORTHOPILOT software THA universal V2 ORTHOPILOT software TKA version 6 ORTHOPILOT software TKR version 3	IIa MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	ACCULAN8 refs ACCULAN 4 SUSI®	I MDR	EUDAMED record Report an error
Electrosurgery instruments - hardware accessories	Z12010980	Aesculap11 refs LEKTRAFUSE	I, IIb MDR	EUDAMED record Report an error
ENT endoscopy instruments - other	Z12021099	Aesculap3 refs M-TRAC®	I MDR	EUDAMED record Report an error
Neuroscopes	Z12020902	Aesculap3 refs PaediScope®2 refs	III MDR	EUDAMED record Report an error
Orthopaedic surgical saws	Z12130502	ACCULAN 43 refs Aesculap3 refs	IIa MDR	EUDAMED record Report an error
Calipers	V030201	Aesculap3 refs	I MDR	EUDAMED record Report an error
Cystourethroscopes	Z12020702	Aesculap3 refs	IIa MDR	EUDAMED record Report an error
Dermotomy equipment	Z120103	ACCULAN 42 refs	IIa MDR	EUDAMED record Report an error
Drills for neurosurgery	Z12100902	ELAN 4 electro drill	IIa MDR	EUDAMED record Report an error
Electrosurgical units (ESU) for general use	Z12010902	Aesculap	IIb MDR	EUDAMED record Report an error
Endoscopic electrosurgical units (ESU)	Z12010904	LEKTRAFUSE	IIb MDR	EUDAMED record Report an error
Gas inflators	Z12029008	FLOW 50	IIa MDR	EUDAMED record Report an error
Goniometers	V030202	Aesculap	I MDR	EUDAMED record Report an error
Instruments for operative microscopy - consumables	Z12011185	AESCULAP AEOS	I MDR	EUDAMED record Report an error
Laryngoscopes	Z12021003	Aesculap3 refs	I MDR	EUDAMED record Report an error
Laser surgery instruments - hardware accessories	Z12011080	Aesculap3 refs	I MDR	EUDAMED record Report an error
Light sources	Z129004	Aesculap	I MDR	EUDAMED record Report an error
Light sources for endoscopy and minimally invasive surgery	Z12020402	Aesculap2 refs	I, IIa MDR	EUDAMED record Report an error
Measurement devices - other	V0399	Aesculap6 refs	I MDR	EUDAMED record Report an error
Medical/medicinal gas pipeline systems and related accessories	Z120309	Aesculap	I MDR	EUDAMED record Report an error
Obstetrics and gynecology measurement devices not included in other classes	V030205	Aesculap2 refs	I MDR	EUDAMED record Report an error
Operative microscopes	Z12011101	AEOS	IIa MDR	EUDAMED record Report an error
Orthopaedic surgical drills	Z12130503	Aesculap3 refs	IIa MDR	EUDAMED record Report an error
Patient positioning instruments - consumables	Z12011285	Aesculap3 refs	I MDR	EUDAMED record Report an error
Patient positioning instruments - hardware accessories	Z12011280	Aesculap3 refs	I MDR	EUDAMED record Report an error
Patient positioning instruments - other	Z12011299	Aesculap4 refs	I MDR	EUDAMED record Report an error
Sternotomes	Z12059010	Aesculap3 refs	IIa MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - consumables	Z12029085	Aesculap93/42	IIa 93/42	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - other	Z12029099	Aesculap2 refs	I MDR	EUDAMED record Report an error
Various orthopaedic and traumatology instruments - other	Z12139099	Aesculap3 refs	I MDR	EUDAMED record Report an error

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