Fabricant

Olympus Winter & Ibe

AllemagneEntités : Olympus Winter & Ibe GmbH

Marchés : Allemagne · États-Unis

Autorisations : UE – classe I, IIa, IIb · États-Unis (FDA) – 510(k) : 43 · classe II · dernière en 2026 · voir sur le site de la FDA

Site web eudamed.regulatoryaffairs@olympus-oste.eu

18 catégories, 182 modèles dont 180 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
Resectoscopes	Z12020707	Adapter, optical forceps in resectoscope sheath A340893/42 Bridge, for 70° telescope and resectoscope93/42 Guiding tube, for probes93/42 Guiding tube, for probes, with retractor93/42 Inner sheath, for 26 Fr. outer sheath93/42 38 autres Inner sheath, for 26 Fr. outer sheath, with A22085A93/42 Inner sheath, long, for WA22018A and WA22019A93/42 Inner sheath, long, for WA22018A/19A, with deflecting tip obturator93/42 Irrigation port, 1 Luer-Lock connector, rotatable93/42 Irrigation port, 1 stopcock, rotatable93/42 Irrigation port, 1 vertical stopcock, fixed93/42 Irrigation port, 2 stopcocks, rotatable93/42 Obturator, 24 Fr.93/42 Obturator, 26 Fr.93/42 Obturator, deflecting tip, 24 Fr.93/42 Obturator, deflecting tip, 26 Fr.93/42 Obturator, optical, 24 Fr.93/42 Obturator, optical, 24 Fr., long93/42 Obturator, optical, 26 Fr.93/42 Obturator, optical, for A42021A93/42 OP telescope, 0°, 5 mm channel93/42 Outer sheath, 26 Fr., 2 stopcocks, rotatable93/42 Outer sheath, 26 Fr., 2 stopcocks, vertical, fixed93/42 Outer sheath, 27 Fr, 2 stopcocks, vertical, fixed93/42 Outer sheath, 27 Fr., 2 stopcocks, rotatable93/42 Outer sheath, 27 Fr., long, rotatable93/42 Outer sheath, 27 Fr., long, rotatable, for tumor resection93/42 Outer sheath, 28 Fr., 2 stopcocks, rotatable93/42 Outer sheath, 8.5 mm / 26 Fr., 2 stopcocks, rotatable93/42 Resection sheath, 24 Fr.93/42 Resection sheath, 24 Fr., with deflecting obturator93/42 Resection sheath, 26 Fr.93/42 Resection sheath, 26 Fr., with deflecting obturator93/42 Resection sheath, 8 mm, for 8.5 mm outer sheath93/42 Telescope, 4 mm, 12°, long93/42 Telescope, 4 mm, 70°, long93/42 Working element, active93/42 Working element, active, for resection in saline93/42 Working element, for probes93/42 Working element, passive93/42 Working element, passive, for resection in saline93/42 Working insert, 24 Fr., 6 Fr. channel93/42 Working insert, 8.5 mm, 8 Fr. channel, for A42021A93/42	I, IIa, IIb 93/42	Fiche EUDAMED Signaler une erreur
Cystoscopes	Z12020701	Attachment, with stopcock, for WA33036A93/42 Bridge for 4 mm telescope3 réf. Cystoscope sheath 17 Fr.3 réf. Obturator 17 Fr.3 réf. Obturator optical, 19.8 Fr.93/42 20 autres Obturator optical, 21 Fr.93/42 Obturator optical, 22.5 Fr.93/42 Obturator optical, 25 Fr.93/42 Obturator, 15.5 Fr., for A20930A93/42 Obturator, 17 Fr., for A20911A93/42 Obturator, 19.8 Ch., for A20916A93/42 Obturator, 19.8 Fr, for A20912A93/42 Obturator, 21 Fr., for A20913A93/42 Obturator, 21 Fr., for A20933A93/42 Obturator, 22.5 Fr., for A20914A/-34A93/42 Obturator, 25 Fr.93/42 OP telescope, 7°, 11 Fr. x 220 mm, 7.5 Fr. channel, angled ocular93/42 Telescope, 4 mm, 0°, HD, autoclavable OES ELITE93/42 Telescope, 4 mm, 12 °, PDD, HD, autoclavable OES ELITE93/42 Telescope, 4 mm, 12°, HD, autoclavable OES ELITE93/42 Telescope, 4 mm, 30 °, PDD, HD, autoclavable OES ELITE93/42 Telescope, 4 mm, 30 °, wide-angle, HD, autoclavable OES ELITE93/42 Telescope, 4 mm, 30°, HD, autoclavable OES ELITE93/42 Telescope, 4 mm, 70 °, PDD, HD, autoclavable OES ELITE93/42 Telescope, 4 mm, 70°, HD, autoclavable OES ELITE93/42	I, IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Genitourinary endoscopy instruments - hardware accessories	Z12020780	Attachment, with automatic valve, for A3336A93/42 Bridge, for 4 mm telescope, cystoscope93/42 Bridge, one way93/42 Bridge, two way93/42 Cystoscope sheath, 15.5 Fr., straight93/42 14 autres Cystoscope sheath, 17 Fr.93/42 Cystoscope sheath, 17 Fr., straight93/42 Cystoscope sheath, 19.8 Fr.93/42 Cystoscope sheath, 19.8 Fr., with ramp, straight, 7 Fr. channel93/42 Cystoscope sheath, 21 Fr.93/42 Cystoscope sheath, 21 Fr., slip off protection93/42 Cystoscope sheath, 22.5 Fr.93/42 Cystoscope sheath, 22.5 Fr., slip off protection93/42 Cystoscope sheath, 25 Fr.93/42 Cystoscope, 30°, 14 Fr. x 230 mm, 7 Fr. channel, straight ocular93/42 Cystoscope, 30°, 17 Fr. x 225 mm, 9 Fr. channel, ocular angle 45°93/42 Sealing cap kink protection, 0.4 mm, black, 6 pieces Working insert, Albarran, one way93/42 Working insert, Albarran, two way93/42	I, IIa MDR, 93/42	Fiche EUDAMED Signaler une erreur
Rhinoscopes	Z12021008	Telescope, 10 mm, 70°, autoclavable93/42 Telescope, 10 mm, 90°, autoclavable93/42 Telescope, 4 mm, 0° ULTRA93/42 Telescope, 4 mm, 0°, connector for light guide on bottom, autoclavable93/42 Telescope, 4 mm, 30° inverse ULTRA93/42 11 autres Telescope, 4 mm, 30° ULTRA93/42 Telescope, 4 mm, 30°, connector for light guide on bottom, autoclavable93/42 Telescope, 4 mm, 30°, connector for light guide on top, autoclavable93/42 Telescope, 4 mm, 45° inverse ULTRA93/42 Telescope, 4 mm, 45° ULTRA93/42 Telescope, 4 mm, 45°, connector for light guide on top, autoclavable93/42 Telescope, 4 mm, 45°, connector for light guide on bottom, autoclavable93/42 Telescope, 4 mm, 70° inverse ULTRA93/42 Telescope, 4 mm, 70° ULTRA93/42 Telescope, 4 mm, 70°, connector for light guide on bottom, autoclavable93/42 Telescope, 4 mm, 70°, connector for light guide on top, autoclavable93/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Hysteroscopes	Z12020704	Obturator, 5 mm93/42 Sheath, 3.0 mm93/42 Sheath, 4 mm93/42 Sheath, 4.5 mm, 5 Fr. channel, continuous irrigation93/42 Sheath, 4.5 mm, continuous irrigation, 3 Fr. channel93/42 10 autres Sheath, 5 mm93/42 Sheath, 5.5 mm, 5 Fr. channel, continuous irrigation93/42 Sheath, 5.5 mm, continuous irrigation, 3 Fr. channel93/42 Sheath, 6.5 mm, continuous flow, 5 Fr. channel93/42 Sheath, 6.5 mm, continuous irrigation, 7 Fr. channel93/42 Telescope, 3 mm, 0°, autoclavable93/42 Telescope, 3 mm, 12°, autoclavable93/42 Telescope, 3 mm, 30°, wideangle, autoclavable93/42 Telescope, 1.9 mm, 0°, 280mm, autoclavable93/42 (plus commercialisé) Telescope, 1.9 mm, 30°, 280 mm, autoclavable93/42 (plus commercialisé)	I, IIa 93/42	Fiche EUDAMED Signaler une erreur
Laparoscopes	Z12029009	Telescope IR, 5.4 mm, 30° ULTRA93/42 Telescope 10 mm, 0° ULTRA93/42 Telescope 10 mm, 30° ULTRA93/42 Telescope 10 mm, 45° ULTRA93/42 Telescope 5.4 mm, 0° ULTRA93/42 6 autres Telescope 5.4 mm, 30° ULTRA93/42 Telescope 5.4 mm, 45° ULTRA93/42 Telescope IR, 10 mm, 30°, short ULTRA93/42 Telescope IR, 5.4 mm, 0° ULTRA93/42 Telescope, 10 mm, 0° IR93/42 Telescope, 10 mm, 30° IR93/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Radiosurgical units	Z12010905	Electrosurgical generator ESG-15093/42 Electrosurgical generator ESG-300 Electrosurgical Generators - ESG-3003 réf. Electrosurgical generator ESG-400 Electrosurgical Generators - ESG-4002 réf. Electrosurgical generator ESG-410 Electrosurgical Generators - ESG-4102 réf. Electrosurgical generator, B-Type CELON ELITE ESG-2002 réf. 4 autres Electrosurgical generator, B-Type CELON Precision2 réf. Foot switch3 réf. Versapoint II Electrosurgical Generator non-sterile, reusable93/42 Versapoint II Footswitch non-sterile, reusable93/42	I, IIb MDR, 93/42	Fiche EUDAMED Signaler une erreur
Arthroscopes	Z12021101	Telescope , 2.7 mm, 30°, autoclavable TrueView II93/42 Telescope, 2.7 mm, 0°, autoclavable TrueView II93/42 Telescope, 2.7 mm, 70°, autoclavable TrueView II93/42 Telescope, 2.7mm, 30°, short, autoclavable TrueView II93/42 Telescope, 4 mm, 0°, with trocar tube connector ULTRA93/42 2 autres Telescope, 4 mm, 30°, with trocar tube connector ULTRA93/42 Telescope, 4 mm, 70°, with trocar tube connector ULTRA93/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Cleaning, disinfection and sterilisation instruments - hardware accessories	Z12011380	Adapter FJF A13 réf. Adapter for ETD, for Fujifilm F-LT2 ETD Adapters - ETD4 Adapter Leakage Tester3 réf. Adapter Fujifilm 1 ETD Adapters - ETD53 réf. Insert tray A05951A3 réf. Instrument basket system A59403 réf. 2 autres Instrument tray, for semi-rigid ureteroscope, with connection to washer-disinfector Leakage tester, for flexible Olympus endoscopes	I MDR	Fiche EUDAMED Signaler une erreur
Argon electrosurgical units (ESU)	Z12010903	Pressure reducer, with connector acc. to BS 341 No. 3, for Argon Plasma Coagulation93/42 Pressure reducer, with connector acc. to CGA No. 580, for Argon Plasma Coagulation93/42 Pressure reducer, with connector acc. to DIN 477 No. 10, for Argon Plasma Coagulation93/42 Pressure reducer, with connector acc. to DIN 477 No.6, for Argon Plasma Coagulation93/42 Pressure reducer, with connector acc. to ISO 5145 No. 4, for Argon Plasma Coagulation93/42 1 autre Pressure reducer, with connector acc. to JIS B8246, for Argon Plasma Coagulation93/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Video laparoscopes	Z12029016	Video telescope , 10 mm, 0° ENDOEYE 3D93/42 Video telescope , 10 mm, 30° ENDOEYE 3D93/42 Video telescope , 10 mm, 30°, autoclavable ENDOEYE HD II93/42 Video telescope , 5.4 mm, 0°, autoclavable ENDOEYE HD II93/42 Video telescope, 5.4 mm, 30°, autoclavable ENDOEYE HD II93/42 1 autre Video telescope, 10 mm, 0°, autoclavable ENDOEYE HD II93/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Cystourethroscopes	Z12020702	Obturator, for A3551, 4 Fr. channel93/42 Outer sheath, 26 Fr., for A355193/42 Sheath, 22 Fr., for urethrotome93/42 Working element, for A355193/42	I, IIa 93/42	Fiche EUDAMED Signaler une erreur
Light sources for endoscopy and minimally invasive surgery	Z12020402	LG-adapter, 90°, OES telescope to OES LG cable3 réf. Light guide, 3 mm, 2,5 m, fluid, plug type, PDD Light source , for flexible endoscopes EndoLED2 réf. Light source , for stroboscopy OLYMPUS CLL-S12 réf.	I MDR	Fiche EUDAMED Signaler une erreur
Various instruments for endoscopy and mini-invasive surgery - other	Z12029099	Trocar spike, 2.7 mm, blunt93/42 Trocar spike, 2.7 mm, blunt, short93/42 Trocar spike, 2.7 mm, triangular93/42 Trocar spike, 2.7 mm, triangular, short93/42	I 93/42	Fiche EUDAMED Signaler une erreur
Various instruments for endoscopy and mini-invasive surgery - hardware accessories	Z12029080	Guiding rod, 4 mm93/42 Trocar spike, 4 mm, blunt93/42 Trocar spike, 4 mm, triangular93/42	I 93/42	Fiche EUDAMED Signaler une erreur
Endoscope washers	Z12011311	Washer-disinfector PAA ETD Double93/42	IIb 93/42	Fiche EUDAMED Signaler une erreur
Genitourinary endoscopy instruments - other	Z12020799	Sheath, 5.25 mm, 5 Fr. channel93/42	IIa 93/42	Fiche EUDAMED Signaler une erreur
Nephroscopes	Z12020705	OP-telescope, 30°, 4 mm channel93/42	IIa 93/42	Fiche EUDAMED Signaler une erreur

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