Manufacturer

Steris

Canada, Italy, United Kingdom (ex Northern Ireland), United StatesLegal entities : STERIS Canada ULC, STERIS Corporation, STERIS IMS Limited

Markets : Belgium · France · Germany · Ireland · Italy · Spain · United States

Approvals : EU – class I, IIa, IIb · United States (FDA) – 510(k) : 230 · class I, II · latest in 2026 · see on the FDA website

Public contracts won : France 42 · Italy 14 · Germany 6 · Spain 3 · Belgium 1

EU representative : STERIS Ireland Ltd (Ireland)

Website ra-emea@steris.com

25 categories, 114 models including 114 on the market, 4 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
Medical cushions - other	V080399	Armboard Pads Back-Seat Table Pads BF2323 refs Carbon Fiber Extensions BF1713 refs Coned-Shaped Headrest3 refs Foot Extension BF23 refs 23 others Head Section Pads BF0963 refs Head Section-Mushroom Attachment3 refs Headrest3 refs Hip Rest2 refs HLT Table Pads3 refs IA Board2 refs Knee Holder BF7172 refs Lateral Brace2 refs Leg Section Pads BF2333 refs Leg Supports BF1183 refs Multifunction Body Cushion3 refs Perineal Pad BF205 Perineal Post BF000653 refs PRS Tabletop pads3 refs Sacral Rest3 refs Shoulder Pads BF4432 refs Table Extension with Pads BF6522 refs Table Extensions BF00033 refs TLT Tabletop Pads3 refs Transfer Board BF2043 refs TrenStop Pad2 refs Urology Extension BF4083 refs X-Ray Tabletop Pads	I MDR	EUDAMED record Report an error
Patient positioning instruments - other	Z12011299	Accessories for orthopedic surgery3 refs Arm Positioner BF00245 Armboard3 refs Backrest extension BACK02B3 refs Bariatric Gastric Package 17 others Digital Table Conversion Kit2 refs Dual Articulating Headrest2 refs Femur Drive2 refs Femur Hook Head Positioner HEAD023 refs Headrest3 refs Hip Spica2 refs Leg Positioner BF002153 refs Leg Positioner-Non-active BF266 Legrest extension3 refs Neuro Headrest Adaptor2 refs Orthopaedic Extension BF002563 refs Orthopedic Extension Accessory Package Power Lift Stirrups Straps and Restraints3 refs Universal Table Top3 refs Urology Package3 refs	I MDR	EUDAMED record Report an error
Endoscope washers	Z12011311	AMSCO 1215 Cart Utensil Washer Disinfector3 refs AMSCO 2532 Single-Chamber Washer Disinfector16 refs93/42 AMSCO 3052 Washer7 refs93/42 AMSCO 5052 Washer7 refs93/42 AMSCO 7052HP Washer Disinfector3 refs 8 others AMSCO 7053HP Washer Disinfector3 refs Reliance Vision17 refs93/42 Vision 1321 Cart and Utensil Washer93/42 Vision 1327 Cart and Utensil Washer2 refs93/42 Vision 1330L Cart and Utensil Washer2 refs93/42 Vision FH8104293/42 Vision FH8107293/42 Vision FH8204293/42	IIa, IIb MDR, 93/42	EUDAMED record Report an error
Patient positioning instruments - hardware accessories	Z12011280	Anaesthesia screen BF0742 refs Cassette Tray BF1372 refs Clamp TA02010843 refs Clamps and Locks BF00023 refs General Table Accessory3 refs 1 other NA BF5393 refs	I MDR	EUDAMED record Report an error
Operating tables	Z12011202	7080 Surgical Table3 refs CMAXXRAY3 refs STERIS 4095 Surgical Table3 refs STERIS 5085 SRT Surgical Table2 refs STERIS 5095 Surgical Table3 refs	I MDR	EUDAMED record Report an error
Scialytic lamp lighting systems - consumables	Z12010785	HarmonyAIR2 refs rShield Radiation Protection Device2 refs Sterile Camera Cover LB542 refs Sterile Light Handle Cover LB533 refs Sterilizable Light Handle3 refs	I MDR	EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - hardware accessories	Z12011380	AMSCO 300 Accessory Steam Sterilizer Accessories-3003 refs RAS Cycle Rack3 refs Steam Sterilizer Accessories-6002 refs Washer Disinfector Rack7 refs	I MDR, 93/42	EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - consumables	Z12011385	CELERITY DART2 refs VERIFY5 refs	I MDR	EUDAMED record Report an error
Fixed scialytic lamps	Z12010701	ALYON3 refs HarmonyAIR9 refs HexaLux3 refs	I MDR	EUDAMED record Report an error
Scialytic lamp lighting systems - hardware accessories	Z12010780	HarmonyAIR7 refs HexaLux Hexalux Wall Plate	I MDR	EUDAMED record Report an error
Various instruments for endoscopy and mini-invasive surgery - other	Z12029099	ENDODRY3 refs SURESTORE SURESTORE Outer Pouches	I MDR	EUDAMED record Report an error
Various instruments for general and multidisciplinary surgery - other	Z12019099	Non-surgically Invasive ENT PH4533103 refs Non-surgically Invasive Gynaecology, Urology, Proctology3 refs Non-surgically Invasive Podiatry3 refs	I MDR	EUDAMED record Report an error
Cleaning and disinfection equipment	Z12011301	MEDIVATORS ISA ISA AER- Disinfectors and Sterilizers3 refs RELIANCE3 refs	IIb MDR	EUDAMED record Report an error
Plasma sterilisers	Z12011309	V-PRO maX 2 Sterilizer3 refs V-PRO S2 Sterilizer3 refs	IIa MDR	EUDAMED record Report an error
Scialytic lamp lighting systems - other	Z12010799	ALYON3 refs HarmonyAIR4 refs	I MDR	EUDAMED record Report an error
Autoclaves with a chamber larger than or equal to 1 standard sterilisation unit	Z12011304	AMSCO 600 Steam Sterilizer3 refs	IIa MDR	EUDAMED record Report an error
Chemical sterilisation equipment	Z12011303	MEDIVATORS ISA3 refs	IIb MDR	EUDAMED record Report an error
Cleaning, disinfection and sterilisation instruments - other	Z12011399	RAPIDAER Hookup3 refs	I MDR	EUDAMED record Report an error
Endoscope sterilisers	Z12011313	Enspire 3000 Proccessor3 refs	IIa MDR	EUDAMED record Report an error
Mobile scialytic lamps	Z12010702	HarmonyAIR2 refs	I MDR	EUDAMED record Report an error
Orthopaedic traction instruments - consumables	Z12130285	Tenzor Pads	I MDR	EUDAMED record Report an error
Remote control tables - hardware accessories	Z11030780	CMAX XRAY Joystick3 refs	I MDR	EUDAMED record Report an error
Surgical medical aspirators	Z120105	Non-surgically Invasive Clinic equipment/Surgical instrument accessories3 refs	I MDR	EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - hardware accessories	Z129080	HexaVue	I MDR	EUDAMED record Report an error
Various instruments for functional exploration and therapeutic interventions - medical device software	Z129092	HexaVue7 refs	I MDR	EUDAMED record Report an error

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