Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instruments
Cleaning, disinfection and sterilisation instruments
EMDN code Z120113
Manufacturers registered in Europe (EUDAMED) 143
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
- Click a manufacturer to see its full range, a model to open its EUDAMED record.
A model registered in EUDAMED is not necessarily sold in your country. Check availability and CE marking with the manufacturer.
Other manufacturers known in the United States (FDA) 433
Manufacturers selling this type of device in the United States according to the FDA, not yet in EUDAMED for this category. Some do sell in Europe: registration of devices already on the market is mandatory until 28 November 2026, and some are registered under their parent company’s name. The category is inferred automatically from the US classification and may include related products.
| Manufacturer | Country | Brands | FDA clearance |
|---|---|---|---|
| Ruhof Corporation | United States | PREMIXSLIP AW (10 Liter SB 63) ENDOZIME XP (4 Liter FB63) ENDOZIME XP (4.2oz/125ml bottle) FACTS (8.45oz/250ml with foam sprayer) PREPZYME (8.45oz/250ml with dropper) ENDOZIME XP (2 Liter RB38) | registered |
| Zimmer, Inc. Present in Europe in other categories | United States | Trilogy® NexGen® Gender Solutions® Natural-Knee® Prolong® | registered |
| Steris Mexico, S. de R.L. de C.V. | – | AMSCO Atlas Amsco Evolution Eagle V-PRO | registered |
| Boston Scientific Corp Present in Europe in other categories | United States | Compliance EndoKit™ Hedgehog Koala™ Compliance BronchKit™ Porpoise™ | registered |
| Batrik Medical Manufacturing Inc Present in Europe in other categories | Canada | Batrik Arc Wire Brushes Single Use Batrik In-Brush Twisted Wire Brushes Sharn Brushes Batrik Arc Channel Brushes Batrik Arc Wire Brushes Reusable Batrik Brush/Blue/BD 8mm/BL 50mm | registered |
| SKYTRON LLC | United States | Integrity Sterilizers Flex Sterling P1800 CleanStart I-Series Washers Sterling Washers | registered |
| GETINGE IC PRODUCTION POLAND SP Z O O | – | Getinge 500 Series Getinge 700 Series Getinge 400 Series | registered |
| KEY SURGICAL, INC. Present in Europe in other categories | United States | Key Surgical Endoscope Brushes Endoscope Brushes Key Surgical Pipe Cleaners | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | Cygnus SafeClean ® General Purpose Brush SafeClean ® Suction Tube Cleaning Brush SafeClean ® Fan Tip Brush SafeClean ® Toothbrush Style SafeClean ® Scope Channel Cleaning Brush | registered |
| TRICOR SYSTEMS, INC. | United States | Dri-Scope Aid - Cabinet - Manifold (M2) - Series 3308 - Solaire Dri-Scope Aid - Connectors Kits - Type F2 (100 pack) Dri-Scope Aid - Jet-Stream - Pressure Test Load Kit (1 pack) Dri-Scope Aid - Cabinet - Pump Ceiling (P4R) - Series 1840 Dri-Scope Aid - Cabinet - Pump Ceiling (P3R) - Series 1840 Dri-Scope Aid - [Gen 2] Cabinet - Regulator Wall (R3) - Series 1840 | registered |
| ALCONOX INC | United States | Alconox Detojet Solujet Tergazyme Liquinox Citranox | registered |
| Aesculap, Inc. Present in Europe in other categories | United States | AESCULAP | registered |
| CYGNUS MEDICAL L.L.C. | – | Ring-Handled Channel Brush Cattails NYLON SMALL DIAMETER PULL-THROUGH CHANNEL BRUSH NoDrip Roll First Step Bedside Kit - Stand-Up Pouch, Endoscopic Cleaning Pad Button Brush, Single-Use & Disposable, Brush Diameter | registered |
| TUTTNAUER ISRAEL LTD. | – | 69120 T-Edge 10 T-Edge 11 5596 69150 6666120 | registered |
| Primed Instruments Inc | Canada | 9000 Series Disposable Channel Cleaning Brush 8000 Series Reusable Channel Cleaning Brush SuperDART® ONE PASS™ Validated Channel Cleaning Kit SuperDART® ONE PASS™ Validated Channel Cleaning Device | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein Maxima Turbo Maxizyme Tablets Temporary Cement Remover Tartar & Stain Remover Maxima | registered |
| Propper Manufacturing Co., Inc. | United States | Propper Strate-Line Autoclave Indicator Tape Propper Blue Autoclave Indicator Tape Propper Duo-Record Steam & Ethylene Oxide Record Keeping Cards Propper OK Strips Propper Vapor Line Integrators Propper OK Sterilization Bags | K240910 (2024) |
| TERRAGENE S.A. | Argentina | VERISURE™ Integron® Bionova® Tuttnauer® Chemdye® SEALSURE™ | K200272 (2020) |
| JMU DENTAL, INC | – | JMU | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline MEDLINE INDUSTRIES, INC. | registered |
| Midmark Corp. Present in Europe in other categories | United States | Midmark Ritter M9 Ultraclave M11 Ultraclave Ritter M9 Ultraclave Ritter M3 UltraFast | K233026 (2024) |
| Karl Storz GmbH & Co. KG Present in Europe in other categories | Germany | n.a. MIP Minimal Invasive PCNL | registered |
| CARGUS INTERNATIONAL, INC | – | MARK3 | registered |
| STERITEC PRODUCT MFG. CO., INC. | – | Getinge Assure Chemisix Sterilization Emulator SteriTec EO Sterilization Indicator Tape Getinge Assure S.M.A.R.T. Green Sterilizer Mechanical Air Removal Test Getinge Sterilization Indicator Tape Ethylene Oxide (EO) Getinge Assured Tape 18mm (Steam) Getinge Assured Mini Bowie-Dick Test Pack | registered |
| HEALTHMARK INDUSTRIES CO., INC. | – | Sanizyme Endoscope Brushes Angled Toothbrush | registered |
| Spsmedical Supply Corp. | United States | DRY HEAT INDICATOR STRIP CHEMICAL VAPOR INDICATOR STEAMPLUS TRAY RECORD CARD DUAL RECORD CARD DRY HEAT INDICATOR LABEL STEAM INDICATOR LABEL | K130211 (2013) |
| Sharn Anesthesia | – | Sharn Inc SharnSelect Sharn Anesthesia | registered |
| HU-FRIEDY MFG. CO., LLC | United States | Enzymax Liquid IMS Daily Clean Enzymax Spray Gel Enzymax PAX Hu-Friedy | registered |
| Ultra Clean Systems, Inc. | – | Xi Adapter 1150 - Lumen tray only Xi Adapter R2 1150 - Lumen Tray with Accessory Kit Sanizyme 15-Gallons Triton series - Lumen tray with an accessory kit | registered |
| ELMED INCORPORATED | United States | ELMED INCORPORATED ELMED | registered |
| Ideate Medical | United States | SteroScope Biopsy Connector Assembly, Type R1, Qty 1 SteroScope Sterilization Container SteroScope Olympus Vent Connector Assembly, Qty 1 SteroScope Pipette Connector Assembly, Type 3, Qty 1 SteroScope Insert Connector Extra Small, Type R1, Qty 1 SteroScope Insert Connector Small Assembly Type 2, Qty 1 | K233762 (2024) |
| MEDISAFE UK LIMITED | – | InnoWave Niagara | registered |
| MicroCare, LLC | United States | Spec Clean Dual Enzymatic Detergent Spec Clean Instrument Cart Detergent & Cart Wash Neutral Spec Clean Rinse Agent Spec Clean Pre Treatment Foam Spray Spec Clean Quad Enzymatic Detergent Spec Clean Evacuation System Cleaner | registered |
| Southmedic, Inc. | Canada | EcoZyme Ultra EcoBase EcoZyme EcoZyme Auto Ecobase Foam Spray Scope Sweeper Dual Action Endoscope Cleaning Brushes | registered |
| QUADRALENE LIMITED | United Kingdom | Xen Neutral+ 15G Xen Enzymatic 5L Xen Universal 15G Xen Xcelerate Xen Neutral 5L Xen Neutral+ 5G | registered |
| PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI | – | Getinge Pack Sterilization Pouch Getinge Pack Self-Seal Pouch Getinge Pack Sterilization Roll | registered |
| Primus Sterilizer Company, LLC | United States | PRIMUS Sterilizer PRIMUS Steam Sterilizer Primus Sterlizer | K233132 (2023) |
| SKLAR CORPORATION | – | Sklar® Sklar | registered |
| METREX RESEARCH, LLC Present in Europe in other categories | – | Metricide Metritest MetriZyme MetriClean 2 EmPower MetriWash | registered |
| Med Saver, Inc. | – | MSI Precision Specialty Instruments | registered |
| NEVS INK, INC. | United States | Nev's Ink Inc. VWR VWR GeneMate Pipette.com Nev's Ink, Inc. | K101580 (2010) |
| F.R.GALANTAI MANUFACTURING COMPANY LIMITED | New Zealand | PULL THRU™ Cleaning Brush | registered |
| US Endoscopy | United States | Small Wonder Double-Header Gemini Duoswift Revital-Ox | registered |
| Yangzhou Fartley Medical Instrument Technology Co., Ltd Present in Europe in other categories | China | Bedside Cleaning Sponge Cleaning Sponge Disposable Cleaning Brush Disposable Biopsy Valve Single Use Cleaning Brush Disposable Distal Tip Protectors | registered |
| Chemische Fabrik Dr. Weigert GmbH & Co. KG | Germany | neodisher MediClean forte ProCare Dent 40 neodisher N neodisher FA neodisher Z neodisher MA | registered |
| Olympus Medical Systems Corp. Present in Europe in other categories | Japan | CHANNEL CLEANING BRUSH Single Use Single-ended Cleaning Brush Single Use Soft Brush Single Use Combination Cleaning Brush | registered |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| Gi Scientific, LLC | United States | Venturi Dry Venturi Clean Venturi MicroDryer | registered |
| Pentax of America, Inc. Present in Europe in other categories | United States | BRANDMAX | registered |
| Conmed Corporation Present in Europe in other categories | United States | CONMED ConMed Blue Bullet | registered |
| Fujifilm Corporation Present in Europe in other categories | Japan | FUJIFILM | registered |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| RZ-Medizintechnik GmbH Present in Europe in other categories | Germany | RZ Medizintechnik GmbH | registered |
| Case Medical Inc. | United States | CASE MEDICAL | K982151 (1999) |
| HOYA CORPORATION | United States | PENTAX Medical PENTAX | registered |
| CROSSTEX INTERNATIONAL, INC. Present in Europe in other categories | United States | EfferZyme Ultrasonic Cleaner Tartar and Stain Remover CrossZyme Concentrated Ultrasonic Cleaner Sani ProZyme Enzymatic Detergent General Purpose Non-Ammoniated Ultrasonic Cleaner Steam Indicator Tape | K143520 (2015) |
| Kerr Corporation Present in Europe in other categories | United States | PeelVue Pro Peel Vue Pro | registered |
| Micro-tech Usa | United States | Air/Water Channel Cleaning Adapter Scope Tip Protector Single End Channel Attached Valve Brush Double Ended Valve Brush + Single Ended Channel Brush Double Ended Valve Brush Single Ended Channel Brush | registered |
| Temptime Corporation | United States | HEATmarker® Time-Temperature Indicators: CT24 HEATmarker® Time-Temperature Indicators: F12 HEATmarker® Time-Temperature Indicators: F9 HEATmarker® Time-Temperature Indicators: F3 HEATmarker® Time-Temperature Indicators: CT36 HEATmarker® Time-Temperature Indicators: CT2 | registered |
| BRANDMAX INC. | United States | BrandMax Tri-Clean BrandMax Sonic Shine | registered |
| DIVERSATEK HEALTHCARE, INC. Present in Europe in other categories | United States | CleanFreak® | registered |
| Avalign Technologies, Inc. | United States | Millennium | registered |
| Avanos Medical, Inc. | United States | Dual-Ended Cleaning Brush Single-Ended Cleaning Brush Endoscope Cleaning Device Utility Cleaning Brush AVANOS | registered |
| Clarus Medical, LLC | United States | Clarus Digital Inspection Scope, 2mm x 200cm Clarus Digital Inspection Scope, 2mm x 110cm Clarus Digital Inspection Scope, 1mm x 110cm, High Definition Clarus Digital Inspection Scope, 2mm x 60cm Clarus Inspection Scope, Long Clarus Digital Inspection Scope, Long | registered |
| Germiphene Corporation | Canada | Gleam Microvac Tres Clean | registered |
| ICP, INC. | United States | Dental City | registered |
| Plastcare USA | – | Plastcare | registered |
| Proguard Health, Inc | United States | PlastCare | registered |
| Bright Supply, Inc. | – | Britedent | registered |
| Keystone Industries | United States | Optimize i-Smile Sky Dental OPTIMUS | registered |
| Sonic Systems, Inc. | United States | Belimed Getinge Sonic Systems, Inc Sonic Systems | registered |
| BENCO DENTAL SUPPLY CO. | – | BENCO | registered |
| DEROYAL INDUSTRIES, INC. Present in Europe in other categories | United States | DeRoyal | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| JIANGSU KANGJIN MEDICAL INSTRUMENT CO.,LTD Present in Europe in other categories | China | – | registered |
| Consolidated Machine Corp. | United States | Consolidated Sterilizer Systems | K220736 (2022) |
| PREMIER DENTAL PRODUCTS COMPANY | United States | Brite Shield Vac Attak™ Green Vac Attak™ | registered |
| Andersen Sterilizers, Inc. | United States | AN1087 Dosimeter, Chemical Indicator AN4000.66 EOGas 4 Ethylene Oxide Gas Sterilizer, SS, 120V AN87 Dosimeter, Chemical Indicator AN85 EO Indicator, Type 1 Process Indicator AN86 EO Indicator, Type 1 Process Indicator AN1036.00 Dosimeter, 14 Units EOG4 3&6 Hour Exposure | K200334 (2020) |
| CEFLA SOCIETA' COOPERATIVA | – | mocom | registered |
| Dynarex Corporation | United States | Self-Sealing Sterilization Pouches, With Internal & External Indicators Sterilization Pouches Self-Sealing Sterilization Pouches, With Internal And External Indicators | registered |
| Plasmapp Co,., Ltd. | South Korea | STERLINK™ STERILINK™ | K231169 (2023) |
| SUNSET HEALTHCARE SOLUTIONS, INC. | United States | CPAP Cleaner Germicidal Deodorizing Cleanser Zoey CPAP Cleaner CPAP Cleaning | registered |
| WISCONSIN ALUMINUM FOUNDRY COMPANY, INC. | United States | All American | registered |
| YOUNG DENTAL MANUFACTURING I, LLC | – | Biotrol Health Sonics DH Nyclave Indicator Labels Nyclave TTS Autoclave Indicator Labels | registered |
| BGSS Company Inc. | – | SAFE DENT | registered |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH | registered |
| Fort Defiance Industries, LLC | United States | – | K243801 (2025) |
| Ortho Dental Lab LLC | – | SmileSet QX105 Ultrasonic Cleaner - Black SmileSet QX105 Ultrasonic Cleaner - Mint SmileSet Rechargeable Ultrasonic Cleaner - Black Smileset Rechargeable Ultrasonic Cleaner – Mint SmileSet QX105 Ultrasonic Cleaner - White Smileset Rechargeable Ultrasonic Cleaner – White | registered |
| Pristine Dental Supplies, Inc. | – | Perfect Sterilization | registered |
| TELEFLEX INCORPORATED Present in Europe in other categories | United States | PILLING | registered |
| Tianjin Newtrans Technology Development | – | 1006-C 1008-C 1004-C 1005-C | registered |
| AIRA, LLC | – | Aira | registered |
| Albert Browne , Ltd. Present in Europe in other categories | United States | VERIFY | registered |
| Flight Dental Systems | – | Flight Dental Systems | registered |
| Ga Health Company Limited | China | andorate® Double-End Cleaning Brush with Port Brush andorate® Double-End Cleaning Brush andorate® Single Use Combination Cleaning Brush andorate® Single-End Cleaning Brush with Port Brush andorate® Port Brush | registered |
| PRISMAN INC. | – | Monolith InstruZyme conc. Monolith Ultrasonic Cleaner Powder conc. Monolith InstruZyme Powder conc. Monolith Ultrasonic Cleaner conc. Monolith Tatar 'n' Stain Remover | registered |
| Zhejiang Chuangxiang Medical Technology Co., LTD. | China | Cleaning Brush | registered |
| AMERICAN MEDICAL ENDOSCOPY, INC. | United States | Strauss Surgical | registered |
| Cook, Inc. | United States | COOK | registered |
| Gyrus Acmi, Inc. Present in Europe in other categories | United States | Gyrus ACMI | registered |
The 100 most active manufacturers are shown, out of 433.
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