Manufacturer

Olympus Winter & Ibe

GermanyLegal entities : Olympus Winter & Ibe GmbH

Markets : Germany · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 43 · class II · latest in 2026 · see on the FDA website

Website eudamed.regulatoryaffairs@olympus-oste.eu

18 categories, 182 models including 180 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
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 others 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	EUDAMED record Report an error
Cystoscopes	Z12020701	Attachment, with stopcock, for WA33036A93/42 Bridge for 4 mm telescope3 refs Cystoscope sheath 17 Fr.3 refs Obturator 17 Fr.3 refs Obturator optical, 19.8 Fr.93/42 20 others 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	EUDAMED record Report an error
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 others 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	EUDAMED record Report an error
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 others 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	EUDAMED record Report an error
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 others 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 (no longer marketed) Telescope, 1.9 mm, 30°, 280 mm, autoclavable93/42 (no longer marketed)	I, IIa 93/42	EUDAMED record Report an error
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 others 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	EUDAMED record Report an error
Radiosurgical units	Z12010905	Electrosurgical generator ESG-15093/42 Electrosurgical generator ESG-300 Electrosurgical Generators - ESG-3003 refs Electrosurgical generator ESG-400 Electrosurgical Generators - ESG-4002 refs Electrosurgical generator ESG-410 Electrosurgical Generators - ESG-4102 refs Electrosurgical generator, B-Type CELON ELITE ESG-2002 refs 4 others Electrosurgical generator, B-Type CELON Precision2 refs Foot switch3 refs Versapoint II Electrosurgical Generator non-sterile, reusable93/42 Versapoint II Footswitch non-sterile, reusable93/42	I, IIb MDR, 93/42	EUDAMED record Report an error
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 others Telescope, 4 mm, 30°, with trocar tube connector ULTRA93/42 Telescope, 4 mm, 70°, with trocar tube connector ULTRA93/42	IIa 93/42	EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - hardware accessories	Z12011380	Adapter FJF A13 refs Adapter for ETD, for Fujifilm F-LT2 ETD Adapters - ETD4 Adapter Leakage Tester3 refs Adapter Fujifilm 1 ETD Adapters - ETD53 refs Insert tray A05951A3 refs Instrument basket system A59403 refs 2 others Instrument tray, for semi-rigid ureteroscope, with connection to washer-disinfector Leakage tester, for flexible Olympus endoscopes	I MDR	EUDAMED record Report an error
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 other Pressure reducer, with connector acc. to JIS B8246, for Argon Plasma Coagulation93/42	IIa 93/42	EUDAMED record Report an error
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 other Video telescope, 10 mm, 0°, autoclavable ENDOEYE HD II93/42	IIa 93/42	EUDAMED record Report an error
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	EUDAMED record Report an error
Light sources for endoscopy and minimally invasive surgery	Z12020402	LG-adapter, 90°, OES telescope to OES LG cable3 refs Light guide, 3 mm, 2,5 m, fluid, plug type, PDD Light source , for flexible endoscopes EndoLED2 refs Light source , for stroboscopy OLYMPUS CLL-S12 refs	I MDR	EUDAMED record Report an error
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	EUDAMED record Report an error
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	EUDAMED record Report an error
Endoscope washers	Z12011311	Washer-disinfector PAA ETD Double93/42	IIb 93/42	EUDAMED record Report an error
Genitourinary endoscopy instruments - other	Z12020799	Sheath, 5.25 mm, 5 Fr. channel93/42	IIa 93/42	EUDAMED record Report an error
Nephroscopes	Z12020705	OP-telescope, 30°, 4 mm channel93/42	IIa 93/42	EUDAMED record Report an error

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