Fabricant

Olympus

JaponEntités : OLYMPUS MEDICAL SYSTEMS CORP.

Marchés : France · Allemagne · Autriche · Belgique · Espagne · Italie · Pays-Bas · Pologne · États-Unis

Autorisations : UE – classe I, IIa, IIb · États-Unis (FDA) – 510(k) : 505 · classe I, II, III · dernière en 2026 · voir sur le site de la FDA

Marchés publics remportés : France 222 · Italie 60 · Allemagne 32 · Espagne 29 · Belgique 17 · Autriche 10 · Pologne 10 · Pays-Bas 2

Mandataire UE : Olympus Europa SE & Co. KG (Allemagne)

25 catégories, 149 modèles dont 149 en vente, 1 pays

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93/42 Ancienne directive, pas encore certifié selon le règlement MDR
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Catégorie	Code EMDN	Modèles enregistrés	Classe	Contact
Video colonoscopes	Z12020606	COLONOVIDEOSCOPE CF-EZ1500DI2 réf.93/42 COLONOVIDEOSCOPE CF-H170I93/42 COLONOVIDEOSCOPE CF-HQ1100DI93/42 COLONOVIDEOSCOPE CF-XZ1200I93/42 COLONOVIDEOSCOPE OLYMPUS CF-EZ1500DL2 réf.93/42 28 autres COLONOVIDEOSCOPE OLYMPUS CF-H170L93/42 COLONOVIDEOSCOPE OLYMPUS CF-HQ1100DL93/42 COLONOVIDEOSCOPE OLYMPUS CF-XZ1200L93/42 COLONOVIDEOSCOPE OLYMPUS PCF-XP1500I2 réf. EVIS EXERA III COLONOVIDEOSCOPE CF-H185I93/42 EVIS EXERA III COLONOVIDEOSCOPE CF-H190I93/42 EVIS EXERA III COLONOVIDEOSCOPE CF-HQ190I93/42 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS CF-H185L93/42 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS CF-H190L93/42 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS CF-HQ190L93/42 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190DL93/42 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-H190TL93/42 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-HQ190L93/42 EVIS EXERA III COLONOVIDEOSCOPE OLYMPUS PCF-PH190L93/42 EVIS EXERA III COLONOVIDEOSCOPE PCF-H190DI93/42 EVIS EXERA III COLONOVIDEOSCOPE PCF-H190TI93/42 EVIS EXERA III COLONOVIDEOSCOPE PCF-HQ190I93/42 EVIS EXERA III COLONOVIDEOSCOPE PCF-PH190I93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE CF-H290I93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE CF-HQ290I93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE OLYMPUS CF-H290ECI93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE OLYMPUS CF-H290L93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE OLYMPUS CF-HQ290L93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE OLYMPUS PCF-H290DL93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE OLYMPUS PCF-H290TL93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE OLYMPUS PCF-H290ZL93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE PCF-H290TI93/42 EVIS LUCERA ELITE COLONOVIDEOSCOPE PCF-H290ZI93/42	IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Various instruments for endoscopy and mini-invasive surgery - hardware accessories	Z12029080	12G-SDI cable 2.9M MAJ-24263 réf. 4K AUTOCLAVABLE CAMERA HEAD OLYMPUS CH-S400-XZ-EA 4K CAMERA HEAD OLYMPUS CH-S400-XZ-EB3 réf. Activation Connector MAJ-2432 AFI COLOR BALANCE CAP MAJ-1588 16 autres ATTACHMENT FOR UWIT MAJ-2011 CONNECTION UNIT MAJ-19282 réf. CONTAINER PROTECTOR MAJ-905 CV INTERFACE CONVERTER MAJ-19162 réf. CYLINDER HOSE WITH SWITCH-OVER VALVE (DIN) MAJ-198693/42 CYLINDER HOSE WITH SWITCH-OVER VALVE (PIN-INDEX) MAJ-198593/42 ENDOALPHA STOP SWITCH FOR OR TABLE MAJ-1882 FOOT SWITCH MAJ-11693 réf. HOLDER FOR HC-RP MAJ-19383 réf. INSUFFLATION TUBE MAJ-59093/42 LEAKAGE TESTER MB-1552 réf. OBCU REMOTE CONTROLLER MAJ-1726 RECEIVER DISH MAJ-1868 REMOTE CONTROL MAJ-1890 VIDEO SCOPE CABLE HOLDER MAJ-1466 WHITE CAP HOLDER MAJ-9603 réf.	I, IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Video bronchoscopes	Z12020802	AIRWAY MOBILESCOPE OLYMPUS MAF-DM293/42 AIRWAY MOBILESCOPE OLYMPUS MAF-GM293/42 BRONCHOVIDEOSCOPE OLYMPUS BF-1TH110093/42 BRONCHOVIDEOSCOPE OLYMPUS BF-1TH120093/42 BRONCHOVIDEOSCOPE OLYMPUS BF-1TQ17093/42 16 autres BRONCHOVIDEOSCOPE OLYMPUS BF-H110093/42 BRONCHOVIDEOSCOPE OLYMPUS BF-H120093/42 BRONCHOVIDEOSCOPE OLYMPUS BF-Q17093/42 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEO SCOPE OLYMPUS BF-UC290F93/42 EVIS EUS ULTRASOUND BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-UCP190F EVIS EXERA III BRONCHOVIDEOSCOPE OLYMPUS BF-XT19093/42 EVIS EXERA Ⅲ BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP190F93/42 EVIS EXERA Ⅲ BRONCHOVIDEOSCOPE OLYMPUS BF-1TH19093/42 EVIS EXERA Ⅲ BRONCHOVIDEOSCOPE OLYMPUS BF-H19093/42 EVIS EXERA Ⅲ BRONCHOVIDEOSCOPE OLYMPUS BF-Q19093/42 EVIS EXERA Ⅲ BRONCHOVIDEOSCOPE OLYMPUS BF-XP19093/42 EVIS EXERA Ⅲ BRONCOVIDEOSCOPE OLYMPUS BF-P19093/42 EVIS LUCERA ELITE BRONCHOFIBERVIDEOSCOPE OLYMPUS BF-MP290F93/42 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE OLYMPUS BF-P29093/42 EVIS LUCERA ELITE BRONCHOVIDEOSCOPE OLYMPUS BF-XP29093/42 LI-92B DP178693/42	IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Video gastroscopes	Z12020511	EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H18593/42 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H19093/42 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H190N93/42 EVIS EXERA III GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ19093/42 EVIS EXERA Ⅲ GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-1TH19093/42 10 autres EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H29093/42 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H290EC93/42 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H290T93/42 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-HQ29093/42 EVIS LUCERA ELITE GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP290N93/42 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-110093/42 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-EZ15002 réf.93/42 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-H17093/42 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XP170N93/42 GASTROINTESTINAL VIDEOSCOPE OLYMPUS GIF-XZ120093/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - hardware accessories	Z12020480	AIR MICROPHONE, THROAT MICROPHONE MAJ-25482 réf. CV INTERFACE CONVERTER 2 MAJ-23633 réf. DVI CABLE 3M MAJ-23163 réf. Endoscopy CAD system OIP-1 FOOT HOLDER MAJ-14333 réf. 3 autres KEYBOARD COVER MAJ-1934 KEYBOARD MAJ-19203 réf. POWER CORD CH MAJ-22813 réf.	I, IIb MDR	Fiche EUDAMED Signaler une erreur
Instruments for operative microscopy - hardware accessories - other	Z1201118099	4K COMBINED CABLE 10M MAJ-23092 réf. AUTO FOCUS UNIT MAJ-23033 réf. FOOT SWITCH MAJ-2301 INFRARED AND BLUE LIGHT FILTER UNIT MAJ-23082 réf. LED LIGHT SOURCE OME-L200 2 autres ORBEYE SURGICAL MICROSCOPE OME-V200 POWER CORD EU MAJ-23133 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Ultrasound scanners - hardware accessories - other	Z1104018099	CHE SOFTWARE OPTION MAJ-23813 réf. EVIS-EUS CONNECTING CABLE E MAJ-17113 réf. FOOT SWITCH MAJ-679 KEYBOARD MAJ-1995 KEYBOARD MAJ-2380 2 autres Probe/Irrigation Plug MD-80793/42 ULTRASONIC PROBE UM-S20-17S93/42	I, IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Upper gastrointestinal tract endoscopy instruments - consumables	Z12020585	DISPOSABLE DISTAL ATTACHMENT D-206-0293/42 DISPOSABLE DISTAL ATTACHMENT D-206-0393/42 DISPOSABLE DISTAL ATTACHMENT D-206-0493/42 DISPOSABLE DISTAL ATTACHMENT D-206-0593/42 DISPOSABLE DISTAL ATTACHMENT D-206-0693/42 1 autre SINGLE USE DISTAL COVER MAJ-23152 réf.93/42	I 93/42	Fiche EUDAMED Signaler une erreur
Instruments for ultrasonic surgery - hardware accessories	Z12010880	POWER CORD KR 4.5m MAJ-23483 réf. Reusable Cordless Transducer TD-410 SONICBEAT Footswitch Connector MAJ-2412 SONICBEAT Transducer TD-SB400 Sonicbeat 5mm, Front-Actuated Grip93/42 THUNDERBEAT Transducer TD-TB40093/42	I, IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Lower gastrointestinal tract endoscopy instruments - hardware accessories	Z12020680	BALLOON CONTROL UNIT OBCU OBCU93/42 ENDOSCOPE POSITION DETECTING UNIT UPD-33 réf.93/42 ENDOSCOPE POSITION MARKING PROBE MAJ-187893/42 HAND COIL MAJ-18592 réf. RESERVOIR TANK MAJ-172793/42	IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Video duodenoscopes	Z12020508	DUODENOVIDEOSCOPE OLYMPUS TJF-Q170V93/42 EVIS EXERA III DUODENOVIDEOSCOPE OLYMPUS TJF-Q190V93/42 EVIS LUCERA ELITE DUODENOVIDEOSCOPE OLYMPUS TJF-Q290V93/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images	Z12020401	EVIS X1 VIDEO SYSTEM CENTER OLYMPUS CV-15002 réf. VIDEO SYSTEM CENTER OLYMPUS CV-1702 réf.93/42	IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Light sources for endoscopy and minimally invasive surgery	Z12020402	EVIS EXERA III VIDEO SYSTEM CENTER OLYMPUS CV-1903 réf. EVIS EXERAⅢ XENON LIGHT SOURCE OLYMPUS CLV-1902 réf.93/42	I, IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Upper gastrointestinal tract endoscopy instruments - hardware accessories	Z12020580	AIR/WATER VALVE MAJ-144493/42 AUXILIARY WATER TUBE MAJ-85593/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Various instruments for endoscopy and mini-invasive surgery - consumables	Z12029085	SINGLE USE BIOPSY VALVE MAJ-21093/42 SINGLE USE SUCTION VALVE MAJ-20993/42	I 93/42	Fiche EUDAMED Signaler une erreur
Bioimaging diagnostic report viewing monitors	Z11900801	4K UHD LCD MONITOR OEV321UH	I MDR	Fiche EUDAMED Signaler une erreur
Gas inflators	Z12029008	HIGH FLOW INSUFFLATION UNIT UHI-493/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Genitourinary endoscopy instruments - hardware accessories	Z12020780	Luer-Split MAJ-20922 réf.	IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - medical device software	Z12020492	OTV-S500 UPGRADE PACK STROBE MAJ-25473 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Instruments for the acquisition and management of endoscopic and minimally invasive surgery images - software accessories	Z12020482	UCES-4 Upgrade Pack5 MAJ-2529 UCES‐4 Upgrade Pack2 réf.	IIb MDR	Fiche EUDAMED Signaler une erreur
Lower gastrointestinal tract endoscopy instruments - consumables	Z12020685	SINGLE USE SPLINTING TUBE ST-CB193/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Multidisciplinary ultrasound scanners (internal and cardiology, etc.)	Z11040104	EVIS EUS ENDOSCOPIC ULTRASOUND CENTER OLYMPUS EU-ME3	IIa MDR	Fiche EUDAMED Signaler une erreur
Nasal pharyngo/laryngoscopes	Z12021005	RHINO-LARYNGOFIBERSCOPE OLYMPUS ENF TYPE XP93/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Remote control units for endoscopy and minimally invasive surgery	Z12020404	MEDICAL CONTROL UNIT FOR　ENDOSURGERY UCES-4 UCES‐4 Upgrade Pack93/42	IIb 93/42	Fiche EUDAMED Signaler une erreur
Thoracoscopes	Z12029017	EVIS LUCERA ELITE PLEURA VIDEOSCOPE OLYMPUS LTF-H29093/42	IIa 93/42	Fiche EUDAMED Signaler une erreur

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