Manufacturer

Stryker

Germany, Switzerland, United StatesLegal entities : Stryker Communications, Inc., Stryker Endoscopy, Stryker GmbH

Markets : Austria · Belgium · France · Germany · Ireland · Italy · Netherlands · Norway · Poland · Portugal · Spain · Sweden · United States

Approvals : EU – class I, IIa, IIb, III · United States (FDA) – 510(k) : 622 · PMA : 4 · class I, II, III · latest in 2026 · see on the FDA website

Public contracts won : France 772 · Spain 185 · Italy 50 · Sweden 38 · Germany 36 · Austria 11 · Netherlands 8 · Norway 8 · Belgium 7 · Poland 5 · Portugal 3 · Ireland 2

EU representative : Stryker European Operations Limited (Ireland)

Website RegulatoryAffairsTE@stryker.com

42 categories, 180 models including 180 on the market, 3 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	08858250000507RS2 refs 08858250000517RV 08858250000518RX 08858250000522RN 08858250000523RQ 43 others 08858250000524RS 08858250000525RU2 refs 08858250000527RY2 refs 08858250000528S23 refs 08858250000530RM 08858250000531RP 08858250000532RR 08858250000533RT 08858250000535RX2 refs 08858250000538S5 08858250000539S7 08858250000540RQ 08858250000541RS2 refs 08858250000542RU 08858250000544RY2 refs 08858250000545S23 refs 08858250000546S43 refs 08858250000547S63 refs 08858250000548S8 08858250000549SA3 refs 08858250000551RV 08858250000552RX3 refs 08858250000554S3 08858250000558SB 08858250000560RW3 refs 08858250000561RY2 refs 08858250000564S6 08858250000565S82 refs 08858250000566SA 08858250000568SE2 refs 08858250000569SG2 refs 08858250000570RZ2 refs 08858250000571S33 refs 08858250000576SD 08858250000577SF 08858251004549TP3 refs 08858251005719TX2 refs NGENIUS 08858250000526RW2 refs NGENIUS 08858250000537S3 nGenius 08858250000543RW2 refs ORTHOLOCK 08858250000536RZ Stryker VariSpeed 08858251001895TQ TGS 08858250000556S7	I, IIa, III MDR	EUDAMED record Report an error
Medical beds - other accessories	V08068099	08858250000298S8 08858250000299SA 08858250000300R23 refs 08858251002007RY 08858251007026T72 refs 12 others ComfortGel 08858250000284RV3 refs EOLE DC4 refs93/42 HAVASU 08858250000303R83 refs iBed Wireless 08858251002473SZ IsoTour 08858250000279S43 refs IsoTour 08858250000282RR3 refs M-1 Cot Fastener 08858250000293RW3 refs M1-Cot Fastener 08858250000294RY3 refs MV3 08858251028126U9 Patient Helper 08858250000301R4 Performance-LOAD 08858250000292RU2 refs Power-LOAD 08858250000291RS	I, IIa MDR, 93/42	EUDAMED record Report an error
Patient transfer stretchers - other	V08050199	08858250000302R62 refs Gynnie 08858250000290RQ3 refs Mini-PRO Pediatric Restraint System (with Modified X-Restraints) 08858251028387V7 Power-PRO 2 08858250000295S23 refs Prime Series 08858250000285RX 5 others Prime Series 08858250000286RZ2 refs Prime Series 08858250000287S32 refs Prime Series 08858250000288S53 refs Prime Series 08858250000289S73 refs Prime Series 08858251002085SL2 refs	I MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - hardware accessories	Z12019080	08858250000611RN3 refs 08858250000622RT3 refs 08858250000627S5 08858251002427SS3 refs 08858251003756TP2 refs 5 others CORE 08858250000625RZ3 refs CORE 08858250000629S93 refs iBur 08858251002014RV2 refs Mill Plus 08858251003757TR3 refs TPX 08858250000487SD	I, IIa MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	AO 08858250000612RQ3 refs BPX 08858251002027S63 refs BPX 08858251002053S73 refs BPX 08858251028115U4 Neptune 08858251003189T83 refs 5 others Neptune 08858251003191ST Neptune 08858251006286TU3 refs Neptune 08858251006287TW2 refs Neptune 2 08858250000621RR3 refs TPX 08858250000486SB2 refs	I, IIa MDR	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - hardware accessories	Z12130580	08858250000640RV 08858250000662S72 refs 08858251004481TE3 refs EZout 08858250000643S32 refs EZout 08858250000673SC3 refs 3 others EZout 08858250000674SE3 refs Maestro 08858250000624RX RemB 08858251003232SG	I, IIa, III MDR	EUDAMED record Report an error
Surgical navigation instruments - consumables	Z12011485	08858250000520RJ 08858250000553RZ 08858250000555S5 08858250000567SC3 refs 08858250000572S53 refs 3 others CranialMask 08858250000521RL OrthoLock 08858250000550RT2 refs SPINEMASK 08858250000510RF	I, IIa MDR	EUDAMED record Report an error
Various orthopaedic and traumatology instruments - other	Z12139099	CORE 08858250000647SB3 refs SmartLife 08858250000634S23 refs SmartLife 08858251002179SW3 refs Stryker F1 08858250000648SD3 refs Stryker F1 08858250000649SF2 refs 2 others System 9 08858251006140SX2 refs System 9 08858251006141SZ	I MDR	EUDAMED record Report an error
Electrosurgery instruments - consumables	Z12010985	MULTIGEN 2 08858251003238SU3 refs OptaBlate 08858251006536TU OptaBlate 08858251007095TS3 refs Venom 08858251003239SW3 refs	IIa, IIb MDR	EUDAMED record Report an error
Electrosurgery instruments - hardware accessories	Z12010980	COLORADO 08858251005914TX CORE 08858251003759TV MULTIGEN 2 08858250000009R52 refs OptaBlate 08858251007130T32 refs	I, IIa, IIb MDR	EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - other	Z12011399	08858250000636S6 08858250000675SG Stryker F1 08858250000650RY3 refs	I MDR	EUDAMED record Report an error
Electric medical beds - other	V08060199	ProCeed 08858251002008S23 refs ProCuity 08858251002172SG SV2 08858251002009S4	I MDR	EUDAMED record Report an error
Orthopaedic surgical drills	Z12130503	CORE 08858251004439TF2 refs System 6 08858251002450SM3 refs System 8 08858251002449T43 refs	IIa MDR	EUDAMED record Report an error
Pneumatic tourniquets	Z12139006	08858251002430SF3 refs SmartPump 08858250000616RY SmartPump 08858251002429SW	I, IIa MDR	EUDAMED record Report an error
Wound treatment equipment	Z12019003	08858251004422SW 08858251004423SY3 refs InterPulse 08858251004424T23 refs	IIa MDR	EUDAMED record Report an error
Electric medical chairs - other	V08020199	TruRize 08858250000277RY Xpedition 08858251006262TE	I MDR	EUDAMED record Report an error
Electrosurgical units (ESU) for general use	Z12010902	MULTIGEN 2 08858251003502SN OPTABLATE 08858251007040SZ	IIb MDR	EUDAMED record Report an error
Instruments for ultrasonic surgery - hardware accessories	Z12010880	08858251004511SW Sonopet 08858250000639SC2 refs	I MDR	EUDAMED record Report an error
Motorised orthopaedic surgery system instruments - other	Z12130599	C2C 08858251004538TJ TPX 08858251003726TE3 refs	IIa MDR	EUDAMED record Report an error
Patient positioning instruments - hardware accessories	Z12011280	Operon 08858250000764SG Operon 08858250000765SJ2 refs	I MDR	EUDAMED record Report an error
Patient transfer chairs	V080502	08858250000297S6 Stair-PRO 08858250000296S4	I MDR	EUDAMED record Report an error
Percutaneous discectomy equipment	Z121301	08858251003761TG3 refs 08858251003762TJ2 refs	IIa, IIb MDR	EUDAMED record Report an error
Sternotomes	Z12059010	08858251002431SH2 refs System 6 08858251002448T23 refs	IIa MDR	EUDAMED record Report an error
Surgical cameras	Z12020405	In-Light Camera 08858251028116U6 StrykeCam 08858250000750S5	I MDR	EUDAMED record Report an error
Surgical smoke evacuation systems	Z12019004	08858250000619S6 08858250000620RP	I MDR	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - software accessories	Z119082	HipCheck 08858251003421SM HipMap Femoroacetabular Impingement Analysis 08858251028125U7	IIa MDR	EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - other	Z129099	08858250000751S7 08858250000752S92 refs	I MDR	EUDAMED record Report an error
Bariatric electric medical beds	V08060106	MV3 08858251004512SY	I MDR	EUDAMED record Report an error
Cleaning and decontamination systems for general and multidisciplinary surgery instruments	Z12011306	08858250000651S2	I MDR	EUDAMED record Report an error
Laparoscopes	Z12029009	AIM (Advanced Imaging Modality) 08858251004947U73 refs	IIa MDR	EUDAMED record Report an error
Medical support equipment - accessories	V0880	08858250000626S3	I MDR	EUDAMED record Report an error
Non-active anti-decubitus medical cushions	V08030102	SofCare 08858250000281RP	I MDR	EUDAMED record Report an error
Orthopaedic endoscopy instruments - other	Z12021199	CORE 08858251003760TE3 refs	IIa MDR	EUDAMED record Report an error
Orthopaedic surgical saws	Z12130502	System 6 08858251002451SP3 refs	IIa MDR	EUDAMED record Report an error
Picture archiving and communication systems	Z110603	08858250000433RN	I MDR	EUDAMED record Report an error
Push wheelchairs	Y122103	Prime TC 08858250000278S2	I MDR	EUDAMED record Report an error
Surgical navigation system	Z12011401	TGS Navigation 08858250000559SD	IIa MDR	EUDAMED record Report an error
Various bioimaging and radiotherapy instruments - consumables	Z119085	08858250000434RQ	I MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - other	Z12029099	AHTO 08858251005747U43 refs	IIa MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - consumables	Z12019085	08858251003190SR	I MDR	EUDAMED record Report an error
Various orthopaedic and traumatology instruments - medical device software	Z12139092	ADAPT FOR GAMMA3 08858251002099SX	IIb MDR	EUDAMED record Report an error
Various orthopaedic and traumatology instruments - software accessories	Z12139082	Flyte 08858250000482S33 refs	I MDR	EUDAMED record Report an error

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