Non-specific consumables for diagnostic instruments
EMDN code Z13
Manufacturers registered in Europe (EUDAMED) 36
- 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) 207
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 |
|---|---|---|---|
| Medica Corp. | United States | PAQ.112X100X100BIOCARE PAQ.400X300X1000/EEG/001050 PAQ.245X300X1000/EEG/NK FV245-30 PAQ.210x140x200/QT-HS80/FX4010-FX8322 ROLLO 114X25X16I.PRINTER PAQ.210X150X300/QT80/BDCK7980 | registered |
| S. L. P. SCIENTIFIC LABORATORY PRODUCTS LTD | – | Sleepsense Embla Grass Natus Neurovirtual Clevemed | registered |
| Carestream Health, Inc. Present in Europe in other categories | United States | DRYVIEW DVB Laser Imaging Film Ultra-speed Medical X-ray Green / MXG Film T-MAT G/RA Film INSIGHT DRYVIEW DVE Laser Imaging Film | registered |
| GRAPHIC CONTROLS ACQUISITION CORP | – | Vermed GE Healthcare | registered |
| Flow X Ray Corporation | United States | PureLife X-Ray Film UnoDent Minimax Bitewing TRX-3 Minimax TRX-S SAFCO D SPEED FILM FILM FSS-54 D CHILD SINGLE FILM BUTTERFLY PACKETS F SPEED | 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) |
| Cardinal Health, Inc. Present in Europe in other categories | United States | Kendall non branded Covidien | registered |
| HENRY SCHEIN, INC. Present in Europe in other categories | United States | Henry Schein | registered |
| 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) |
| Palodex Group OY Present in Europe in other categories | Finland | Imaging Plates OCCLUSAL 4C KIT SCAN EXAM OCCLUSAL 4C START-UP KIT | registered |
| 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) |
| A-M SYSTEMS, LLC | United States | Chart Paper, Thermal, for Cosmed Pony FX Spirometer Chart, X-Ref Puritan Bennett 089028 Chart, X-Ref Ohio Med 617-0020-300, 5" x 200', 8L Chart, X-Ref Puritan Bennett 4020 Chart Paper Thermal For PB900 4 9/32" x2 1/4" Chart, X-Ref Collins Apex 22023 11" x 19.625", Grn | registered |
| Air Techniques, Inc. Present in Europe in other categories | United States | Phosphor Storage Plate Phosphor Storage Plate Guide Size 2 Phosphor Storage Plate Guide Size 3 Plate Transfer Box Phosphor Storage Plate Guide Size 4 Phosphor Storage Plate Guide Size 0 | registered |
| Neurovirtual USA, Inc. Present in Europe in other categories | United States | Neurovirtual | K201495 (2020) |
| TYPENEX MEDICAL LLC Present in Europe in other categories | United States | Rad Control IRRADIATION INDICATOR TAG | registered |
| 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) |
| OWENS & MINOR DISTRIBUTION, INC. | – | MediChoice | registered |
| 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) |
| Welch Allyn, Inc. Present in Europe in other categories | United States | Welch Allyn, Inc. | registered |
| BENCO DENTAL SUPPLY CO. | – | VISION XR | registered |
| Fukuda Denshi USA, Inc. Present in Europe in other categories | United States | FUKUDA DENSHI | K852487 (1985) |
| Avante | – | Waveline Pro+ | registered |
| 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 |
| Philips Medizin Systeme Böblingen GmbH Present in Europe in other categories | Germany | Paper Avalon ECG/IUP Transducer Fetal monitoring recording paper Thermal Printer Kit, USB Avalon Toco+ MP Transducer Avalon Toco+ Transducer | 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) |
| Cardinal Health 200, LLC Present in Europe in other categories | United States | CARDINAL HEALTH Kendall | registered |
| 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 |
| DARBY DENTAL SUPPLY, LLC | – | Darby Dental Supply, LLC | registered |
| SAFCO DENTAL SUPPLY CO. | United States | Safco panoramic film Safco X-Pose intraoral x-ray film Safco duplicating film | registered |
| Young Innovations, Inc. | United States | The Orthodontic Store | registered |
| BresoTec Inc | Canada | BresoDX1 Tape Strips BresoDX1 Accessory Kit BresoDX1 BresoSensor Frame BresoDX1 Master Kit BresoDX1 Main Kit BresoDX1 BresoSensor | K220012 (2022) |
| Physio-Control Corp. Present in Europe in other categories | United States | 50mm x 22m ECG Printer Paper (3/roll) ECG PRINTER PAPER, 100MM ECG PRINTER PAPER 50MM CABLE, PRINTER, LP35 100mm x 22m ECG Printer Paper (2/roll) KIT, PRINTER, LP35 | K881346 (1988) |
| NATIONAL DISTRIBUTION & CONTRACTING, INC. | – | Quala | registered |
| 3D DENTAL DESIGNS AND DEVELOPMENT, LLC | – | Visionary by 3D Dental | registered |
| ADVANCED INSTRUMENTATIONS, INC. | United States | ADVANCED PATIENT MONITOR | registered |
| BOUND TREE MEDICAL, LLC | – | Curaplex | registered |
| 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) |
| Edan Instruments, Inc. Present in Europe in other categories | China | Patient Monitor | registered |
| 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) |
| Philips Medical Systems Hsg | – | Paper | registered |
| 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 |
| Draeger Medical Systems, Inc. Present in Europe in other categories | United States | SHP UNT R50 RECORDER UNIVERSA INFINITY R50-N RECORDER Infinity R50-S Recorder | 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) |
| Bio/Data Corp. Present in Europe in other categories | United States | Printer Paper Profiler Paper | registered |
| 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 |
| MEDSOURCE INTERNATIONAL LLC | – | MedSource Defibrillator Paper MedSource EKG Paper | registered |
| PRANAQ PTE. LTD. | Singapore | TipTraQ | K243268 (2025) |
| SKANRAY TECHNOLOGIES LIMITED Present in Europe in other categories | India | STAR 65 | registered |
| SPACELABS HEALTHCARE (WASHINGTON), INC Present in Europe in other categories | – | Spacelabs Healthcare Intesys Clinical Suite | registered |
| 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) |
| Fisher Scientific Co., LLC | United States | Fisherbrand | registered |
| Ge Medical Systems Information Technologies Present in Europe in other categories | United States | – | K905856 (1991) |
| Guangzhou Xinbo Electronic Co., Ltd. Present in Europe in other categories | China | DR -HOS | K200402 (2020) |
| MEDLINE INDUSTRIES, INC. Present in Europe in other categories | United States | Medline | registered |
| MEDTRONIC PS MEDICAL, INC. | United States | – | registered |
| 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) |
| Sibel Health Inc. Present in Europe in other categories | United States | ANNE Sleep | registered |
| Sun Nuclear Corp. Present in Europe in other categories | United States | Precision Cut GafChromic™ Film | registered |
| Therabody, Inc. | United States | Therabody | registered |
| Tone-A-Matic International, Inc. | Canada | TONE-A-MATIC | K221724 (2022) |
The 100 most active manufacturers are shown, out of 207.
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