Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instrumentsCleaning, disinfection and sterilisation instruments
Cleaning, disinfection and sterilisation instruments - consumables
EMDN code Z12011385
Manufacturers registered in Europe (EUDAMED) 26
- On the market
- No longer marketed
- 93/42 Former directive, not yet certified under the MDR
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Other manufacturers known in the United States (FDA) 132
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 |
|---|---|---|---|
| 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 |
| 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 |
| CARGUS INTERNATIONAL, INC | – | MARK3 | 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) |
| ADVANCED STERILIZATION PRODUCTS SERVICES INC. Present in Europe in other categories | – | Tyvek® CIDEX™ SEALSURE™ AUTOSURE™ STERRAD™ | registered |
| PMS TIBBI CIHAZLAR TEKNOLOJISI SANAYI VE TICARET ANONIM SIRKETI | – | Getinge Pack Sterilization Pouch Getinge Pack Self-Seal Pouch Getinge Pack Sterilization Roll | registered |
| HU-FRIEDY MFG. CO., LLC | United States | Hu-Friedy | registered |
| NEVS INK, INC. | United States | Nev's Ink Inc. VWR VWR GeneMate Pipette.com Nev's Ink, Inc. | K101580 (2010) |
| Case Medical Inc. | United States | CASE MEDICAL | K982151 (1999) |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein MAXITEST | registered |
| Kerr Corporation Present in Europe in other categories | United States | PeelVue Pro Peel Vue Pro | registered |
| SKLAR CORPORATION | – | Sklar® | 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 |
| MCKESSON MEDICAL-SURGICAL INC. | – | McKesson | registered |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline MEDLINE INDUSTRIES, INC. | registered |
| ICP, INC. | United States | Dental City | registered |
| Plastcare USA | – | Plastcare | registered |
| Proguard Health, Inc | United States | PlastCare | registered |
| Bright Supply, Inc. | – | Britedent | registered |
| BENCO DENTAL SUPPLY CO. | – | BENCO | registered |
| Aesculap, Inc. Present in Europe in other categories | United States | AESCULAP | registered |
| CROSSTEX INTERNATIONAL, INC. Present in Europe in other categories | United States | Steam Indicator Tape STEAMPLUS STERILIZATION INTEGRATOR VH202 INDICATOR STRIP RED Chemical Indicator Label Steam Indicator Strip | K143520 (2015) |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | 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) |
| Dynarex Corporation | United States | Self-Sealing Sterilization Pouches, With Internal & External Indicators Sterilization Pouches Self-Sealing Sterilization Pouches, With Internal And External Indicators | registered |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| BGSS Company Inc. | – | SAFE DENT | registered |
| Pristine Dental Supplies, Inc. | – | Perfect Sterilization | registered |
| AIRA, LLC | – | Aira | registered |
| Plasmapp Co,., Ltd. | South Korea | STERLINK™ | registered |
| TUTTNAUER ISRAEL LTD. | – | TIVA8-MD TIVA2 TD TIVA2-H TD TIVA10-1V-HS-MD TIVA10-2V-HS-MD | registered |
| INTEGRA LIFESCIENCES PRODUCTION CORPORATION Present in Europe in other categories | United States | Integra® Miltex® Integra® Jarit® | registered |
| MAXILL, INC. | United States | AUTOCLAVE TAPE u-test SI Steam Sterilization Integrator | registered |
| MESA LABORATORIES, INC. | United States | ProChem SSW ProChem EXT Bowie Dick Type Test Mesa Labs Dry Heat Indicator Labels | registered |
| METREX RESEARCH, LLC Present in Europe in other categories | – | Metricide Metritest | registered |
| Dukal LLC | United States | DUKAL | registered |
| Tianchang Jiarui Medical Material Co., Ltd. | – | CARATE | registered |
| True Indicating, LLC | United States | True Indicating Cheeta Larr | K242860 (2025) |
| CENORIN, L.L.C. | United States | Cenorin | K183444 (2019) |
| Dental Health Products Inc | – | DHP/Health-Tec Sterilization Tape | registered |
| PATTERSON DENTAL SUPPLY, INC. | United States | Patterson® | registered |
| Serim Research Corp. | United States | Serim® GUARDIAN™ Peracetic Acid Test Strips Serim® DISINTEK™ OPA Test Strips | K251035 (2025) |
| W&H Sterilization S.R.L. Present in Europe in other categories | Italy | Talos+ RIW-100UC Talos+ RIW-100TT | registered |
| YOUNG DENTAL MANUFACTURING I, LLC | – | DH Nyclave Indicator Labels Nyclave TTS Autoclave Indicator Labels | registered |
| 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | – | Frontier Dental by 3D Dental Design | registered |
| AMD Medicom Inc | Canada | Medicom SafeSeal | registered |
| Avalign Technologies, Inc. | United States | Millennium | registered |
| CERTOL INTERNATIONAL, LLC | – | ProChek S | registered |
| CIVCO Medical Instruments Co., Inc. | United States | UltrOx | registered |
| CPAC EQUIPMENT, INC. | United States | STERIDENT | registered |
| CS MEDICAL, LLC | United States | QwikCheck® | registered |
| Healthlink | – | BOWIE-DICK TYPE TEST PACK pkg of 20 tests | registered |
| MEDICAL ACTION INDUSTRIES INC. | United States | Medical Action Industries | registered |
| MEDICAL CHEMICAL CORPORATION | United States | Wavicide MEC Indicator | registered |
| MicroCare, LLC | United States | ProChek S | registered |
| PEARSON DENTAL SUPPLIES, INC. | – | N' Sure EZTest Bio Stream Indicators | registered |
| Sultan Healthcare Inc | – | SPOROX® | registered |
| TSO3 Inc | United States | STERIZONE® CI+ Chemical indicator | K141698 (2014) |
| Virox Technologies Inc | – | Prevention | registered |
| AD Supply Group Limited | United Kingdom | – | registered |
| ANQING CLEAN DENTAL INSTRUMENT TECHNOLOGY CO.,LTD | China | – | registered |
| ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories | United States | – | registered |
| AT-OS S.r.l. Present in Europe in other categories | Italy | – | registered |
| Advanced Sterilization Products Present in Europe in other categories | United States | – | K234084 (2024) |
| Amcor Flexibles | United States | – | registered |
| Anhui Ares Medical Technology Co.,Ltd. | China | – | registered |
| BGSS COMPANY ASIA LIMITED | China | – | registered |
| BenQ Materials Corp. Yunlin Factory 3 | Taiwan | – | registered |
| CBR Enterprise Limited | Hong Kong SAR China | – | registered |
| COLTENE/WHALEDENT INC Present in Europe in other categories | United States | – | registered |
| Canadian Technical Tape, Ltd. | United States | – | K161024 (2016) |
| Cefla S.C. Present in Europe in other categories | Italy | – | registered |
| Coast Pneumatics, Inc. | United States | – | registered |
| Crosstex International, Inc. (A Cantel Medical Company) Present in Europe in other categories | United States | – | K200096 (2021) |
| DENTSPLY SIRONA INC | United States | – | registered |
| DORT-A TIP MALZ SAN ITH IHR TIC LTD STI | Türkiye | – | registered |
| Dongguan SafeSecure Medical Packaging Co., Ltd | China | – | registered |
| Eikon Device Inc. | Canada | – | registered |
| Fomed Industries, Inc. | China | – | registered |
| GUANGDONG MAIDI MEDICAL CO.,LTD | China | – | registered |
| Getinge Present in Europe in other categories | United States | – | K031647 (2003) |
| HI MEDICAL CO., LTD. | South Korea | – | registered |
| HOGY MEDICAL CO., LTD. | Japan | – | registered |
| HUBEI QIANJIANG KINGPHAR MEDICAL MATERIAL CO., LTD | China | – | registered |
| Hi-Tech Products Inc. | United States | – | registered |
| Hi-Tech Products de Mexico S.A. de C.V. | Mexico | – | registered |
| Hubei Guarddent Medical Technology Co.,Ltd | China | – | registered |
| Ibt Scientific | United States | – | K263267 (2026) |
| Imperial Trading Limited | Barbados | – | registered |
| Indilab, Inc. | United States | – | K110369 (2011) |
| Innopex Limited | Canada | – | registered |
| Intertape Polymer, Inc. | United States | – | K260181 (2026) |
| Jiangmen New Era External Drug Use Co., Ltd. | China | – | registered |
| Jiangmen New Era External Use Drug Co., Ltd. | China | – | K241036 (2024) |
| Jiangsu jsongmed medical materical co.,ltd | China | – | registered |
| Kem Medical Products Corp. | United States | – | K241836 (2024) |
| Lantor Group | United Kingdom | – | K882756 (1988) |
| Mainline Medical Dental Supply | Canada | – | registered |
The 100 most active manufacturers are shown, out of 132.
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