Non-specific consumables for diagnostic instruments
Non-specific consumables for diagnostic instruments - other
EMDN code Z1399
Manufacturers registered in Europe (EUDAMED) 40
- 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) 133
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 |
|---|---|---|---|
| S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD | – | Sleepsense Embla Grass Natus Neurovirtual Clevemed | registered |
| Somnomedics GmbH Present in Europe in other categories | Germany | SOMNOtouch RESP accessory SOMNOscreen plus Accessory SOMNO RESP accessory | K212325 (2022) |
| Respironics, Inc. Present in Europe in other categories | United States | zRIP Alice NightOne ezRIP Alice PDx Pro-Flow Sensor | K183625 (2019) |
| DYMEDIX DIAGNOSTICS, INC. Present in Europe in other categories | United States | TriplePlay SnuggleFit AccuSnore | K200654 (2020) |
| Embla Systems | Canada | Xltek Natus Embla Systems | K180001 (2019) |
| Advanced Brain Monitoring, Inc. Present in Europe in other categories | United States | Night Shift PoSAS | K172799 (2018) |
| Pharmaceutical Innovations, Inc. | United States | Pharmaceutical Innovations | registered |
| Braebon Medical Corp. Present in Europe in other categories | Canada | BRAEBON MediByte BRAEBON MediByte Jr. BRAEBON MediByte Jr. Kit BRAEBON Q-Snor Kit BRAEBON Ultima Snore Sensor BRAEBON Ultima Snoring Sensor with Keyhole Connector | K061764 (2006) |
| Nox Medical ehf. | Iceland | Nox RIP Belts Disposable Medium Nox RIP Belts Disposable Large Nox RIP Belts Disposable X-Large Nox RIP Belts Disposable Small Nox RIP Belts Disposable Pediatric Nox RIP Belts and Cannula Kit S/M/L | K151361 (2015) |
| Onera B.V. Present in Europe in other categories | Netherlands | Onera STS Onera STS 2 | K243220 (2025) |
| COMPUMEDICS LIMITED Present in Europe in other categories | Australia | Compumedics Quik-Gel Compumedics Somte Compumedics Somfit Compumedics Falcon Compumedics Grael Compumedics Somfit D | K252383 (2025) |
| Neurovirtual USA, Inc. Present in Europe in other categories | United States | Neurovirtual | K201495 (2020) |
| Itamar Medical , Ltd. Present in Europe in other categories | Israel | WatchPAT ONE Watch-PAT300 Tamper-Proof Bracelets (24), WatchPAT Central Plus Sensor WatchPAT ONE-M 12 Adhesive Foam Disk 2side For Itamar SBP | K254042 (2026) |
| Watermark Medical, Inc. | United States | ARES Secure Sleep Study Accessories ARES COC Dongle ARES 620 Respiration Effort System ARES620 Respiration Adapter Assembly ARES620 Respiration Module Assembly ARES 620 Unicorder System | K160499 (2017) |
| Nihon Kohden America, Inc. Present in Europe in other categories | United States | Elefix skinPure Elefix V Paste for EEG & EMG | K191975 (2020) |
| Nuface | – | NuFACE | registered |
| Resmed, Ltd. Present in Europe in other categories | United States | AirView myAir AirMini APNEALINK ResMed | K143272 (2015) |
| CADWELL INDUSTRIES, INC. Present in Europe in other categories | United States | Cadwell Cadwell BlueBird EasyNet ApneaTrak | K242424 (2024) |
| Neurotronics, LLC Present in Europe in other categories | United States | Polysmith Version 10.0 Polysmith Version 12.2 NomadAir PMU810 RIP Belt, Medium NomadAir PMU810 Portable Recorder Polysmith Version 12.0 NomadAir PMU810 RIP Belt, Small | K971803 (1997) |
| XLTEK | Canada | Xltek Natus | registered |
| BresoTec Inc | Canada | BresoDX1 Tape Strips BresoDX1 Accessory Kit BresoDX1 BresoSensor Frame BresoDX1 Master Kit BresoDX1 Main Kit BresoDX1 BresoSensor | K220012 (2022) |
| D. O. WEAVER AND COMPANY | United States | Ten20 Conductive Paste | K964737 (1997) |
| Eb Neuro S.P.A. Present in Europe in other categories | United States | BE Micro Recorder BE Micro 21 CH MONO PLUG-IN HEADBOX BE Micro PLUG-IN HEADBOX 19 CH MONO+2CH BIPOL BE Micro Headbox BE Micro | K061996 (2006) |
| Electro-Cap Intl., Inc. | United States | ELECTRO-GEL 32 OZ. BOXED ELECTRO-GEL 16OZ. BOXED ELECTRO-GEL 128OZ ELECTRO-GEL 32oz ELECTRO-GEL 16oz | K111717 (2012) |
| BEAR DOWN CONSULTING | – | PURE ENRICHMENT | registered |
| Eco-Med Pharmaceutical Inc | – | Ecogel 300 | registered |
| Huxley Medical | United States | SansaTM | K252497 (2025) |
| NEUROTRON MEDICAL, INC. | United States | TheraMist PDC Restorer Relief Medical | registered |
| Shenzhen Yuwen E-Commerce Co., Ltd. | China | AUVON | registered |
| Cardinal Health, Inc. Present in Europe in other categories | United States | Covidien | registered |
| NSE PRODUCTS, INC. | United States | Nu Skin RenuSpa iO Package Nu Skin Facial Spa Package Nu Skin Conductive Gel | registered |
| Salter Labs Present in Europe in other categories | United States | – | K151874 (2016) |
| Shenzhen Ulike Smart Electronics Co., Ltd. | China | JMOON | K243749 (2025) |
| Top-Rank Health Care Co., Ltd. Present in Europe in other categories | China | Medvat FyneLook | K222770 (2022) |
| WITHINGS Present in Europe in other categories | France | Withings® | K231667 (2024) |
| Wesper, Inc. | United States | Wesper Lab CASSIE | K252628 (2026) |
| Zephyr Sleep Technologies | Canada | MATRx plus | K200695 (2020) |
| Dynarex Corporation | United States | Electrically Conductive Gel (ECG) | registered |
| Ectosense NV | Belgium | NightOwl | K220028 (2022) |
| Ensodata, Inc. | United States | EnsoSleep PPG Celeste+ | K231355 (2024) |
| General Sleep | – | Zmachine | registered |
| HOME CARE TECHNOLOGY CO., LTD. | United States | Home Care | registered |
| PRANAQ PTE. LTD. | Singapore | TipTraQ | K243268 (2025) |
| Snap Diagnostics, LLC | United States | Model 8 Model 7 | K240100 (2024) |
| Solventum US LLC Present in Europe in other categories | United States | Solventum™ | registered |
| Spes Medica Srl Present in Europe in other categories | Italy | AC Cream - Conductive Paste SAC2 - Electrode Cream | K212326 (2021) |
| APNEICARE, LLC | United States | APNEICARE CONNECTION CENTER/INTERNET ANALYSIS | K082968 (2009) |
| AXIOBIONICS | United States | Spectra 360 Electrode Gel | registered |
| Acurable Limited Present in Europe in other categories | United Kingdom | AcuPebble | K243092 (2025) |
| Axion USA LLC Present in Europe in other categories | United States | Axion | registered |
| Cerebra Medical Ltd | Canada | MICHELE SLEEP SCORING SYSTEM | registered |
| Cognita Labs, LLC | United States | PulmoScan | K191876 (2020) |
| ENDYMED MEDICAL LTD | Israel | EndyGel | K161715 (2017) |
| Guangzhou Xinbo Electronic Co., Ltd. Present in Europe in other categories | China | DR -HOS | K200402 (2020) |
| MYCARDIO LLC | United States | SleepImage System | K092003 (2009) |
| Motive Health, Inc. | United States | QB1 Electrode Gel | registered |
| Myt Enterprises LLC | – | Medvat | registered |
| North East Monitoring, Inc. | United States | Holter Analysis Software Apnea | K081861 (2008) |
| Prizm Medical, Inc. | United States | Thera-Cream | K032239 (2004) |
| RESMED ASIA PTE. LTD. | – | NIGHTOWL | registered |
| RESONEA, INC. | United States | DROWZLE Pro | K173974 (2019) |
| SKANRAY TECHNOLOGIES LIMITED Present in Europe in other categories | India | STAR 65 | registered |
| Sibel Health Inc. Present in Europe in other categories | United States | ANNE Sleep | registered |
| Therabody, Inc. | United States | Therabody | registered |
| Tone-A-Matic International, Inc. | Canada | TONE-A-MATIC | K221724 (2022) |
| Amrex-Zetron, Inc. | United States | – | registered |
| B.Y. Medimor Ltd | Israel | – | registered |
| BSG Corp. | United States | – | registered |
| Bear Down Brands, LLC | United States | – | registered |
| Belun Technology Company Limited | Hong Kong SAR China | – | K222579 (2023) |
| Beurer Far East Ltd. | Hong Kong SAR China | – | registered |
| Brainmatterz, LLC | United States | – | registered |
| CEVA Logistics Netherlands BV | Netherlands | – | registered |
| COGENT TECHNOLOGY LIMITED | United Kingdom | – | registered |
| Carol Cole Company | United States | – | K161654 (2016) |
| Consolidated Research, Inc. | United States | – | registered |
| Convergent Dental, Inc. | United States | – | registered |
| Covidien, LLC Present in Europe in other categories | United States | – | registered |
| DEMANT A/S | Denmark | – | registered |
| Dormotech Medical, Ltd. | Israel | – | K242290 (2025) |
| Ducommun LaBarge Technologies | United States | – | registered |
| East West | United States | – | registered |
| GVS FILTER TECHNOLOGY UK LTD Present in Europe in other categories | United Kingdom | – | registered |
| Gemore Technology Co, Ltd. Present in Europe in other categories | Taiwan | – | registered |
| Goodier Cosmetics LLC | United States | – | registered |
| HAPPY HEALTH, INC. | United States | – | K242224 (2025) |
| Hivox Biotek, Inc. | Taiwan | – | registered |
| Huneo, LLC | United States | – | K260050 (2026) |
| Innokas Yhtyma Oy Present in Europe in other categories | Finland | – | registered |
| Inovise Medical, Inc. | United States | – | K151433 (2016) |
| Ixensor Co, Ltd. | Taiwan | – | registered |
| JIANGYIN SINBON ELECTRONICS CO LTD | China | – | registered |
| Jaeger Medical GmbH Present in Europe in other categories | Germany | – | registered |
| KIMBALL SOLUTIONS GROUP, LLC | United States | – | registered |
| KRENERB | United States | – | registered |
| Largan Medical Co., Ltd. Present in Europe in other categories | Taiwan | – | K233501 (2024) |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | – | registered |
| Mallinckrodt Hospital Products IP Limited | Ireland | – | registered |
| MeHow Innovative (Huizhou) Ltd. | China | – | registered |
| Medical Graphics Corp. Present in Europe in other categories | United States | – | K152585 (2016) |
The 100 most active manufacturers are shown, out of 133.
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