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Emdyca

Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instruments

Nervous system monitoring systems

EMDN code Z121002

14 manufacturers, 270 models including 262 on the market, 9 countries

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Manufacturers registered in Europe (EUDAMED) 14
  • 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.
ManufacturerCountryRegistered modelsClassContact
Friendshipmedical FDA EU representative : Friendship Europe ApS (Denmark) China
217 others
I, IIa MDR, 93/42 Website EUDAMED record Report an error
Inomed FDA Germany
13 others
IIa MDR, 93/42 Website info@inomed.com EUDAMED record Report an error
Dr. Langer Medical Germany
1 other
I, IIa MDR Website info@medical-langer.de EUDAMED record Report an error
Cadwell FDA EU representative : AR Experts B.V. (Netherlands) United States I, IIa MDR Website info@cadwell.com EUDAMED record Report an error
MedEvolve EU representative : RS Consultancies (Netherlands) United Kingdom (ex Northern Ireland) I MDR Website EUDAMED record Report an error
Empatica FDA Italy IIa MDR Website info@empatica.com EUDAMED record Report an error
Medtronic FDA EU representative : Medtronic B.V. (Netherlands) United States IIa MDR EUDAMED record Report an error
EB Neuro FDA Italy IIb MDR Website info@ebneuro.com EUDAMED record Report an error
Institut Du Cerveau Et De La Moelle Epiniere France I MDR Website EUDAMED record Report an error
NCCMedical Pte EU representative : Medical Technology Promedt Consulting GmbH (Germany) Singapore IIa MDR EUDAMED record Report an error
Neuro Event Labs FDA Finland I 93/42 Website contact@neuroeventlabs.com EUDAMED record Report an error
Shanghai NCC Electronic EU representative : RIOMAVIX SOCIEDAD LIMITADA (Spain) China IIb MDR EUDAMED record Report an error
Μεντιγουει Εισαγωγη & Εμπορια Ιατρικων Νοσοκομειοακων Μηχανηματων Μ. Ε.Π.Ε Greece III MDR Website EUDAMED record Report an error
Magstim FDA EU representative : Technomed Europe (Netherlands) No model still on the market United Kingdom (ex Northern Ireland)
3 others
IIa 93/42 Website regulatorymagstim@welcony.com EUDAMED record Report an error

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) 181

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.

ManufacturerCountryBrandsFDA clearance
Nuvasive, Inc. Present in Europe in other categories United States ReLine PULSE MaXcess NVM5 Armada MAS PLIF K112717 (2012)
Technomed Engineering B.V. – Neurosign V4 Technomed Europe Neuroradium Inomed Cadwell Neuroguard registered
Rhythmlink International, LLC Present in Europe in other categories United States Rhythmlink® RHYTHMLINK INTERNATIONAL, LLC Rhythmlink K200984 (2020)
Neurovision Medical Products, Inc. Present in Europe in other categories United States Dragonfly® Nerveana® Nerveana+® Nerveäna+® Nerveana K121931 (2012)
DIAGNOSYS LLC Present in Europe in other categories United States Espion Envoy Mini-OLED ColorDome Desktop Ganzfeld Stimulator ColorBurst Handheld Stimulator EER Stimulator and Amplifier ColorFlash Handheld Stimulator K221471 (2022)
Spes Medica Srl Present in Europe in other categories Italy IOM Stimulator Probes Dragonfly Laryngeal Surface Electrodes Spes Medica Subdermal Needle Electrodes K192603 (2019)
LifeSync Corporation United States Horizon™ Rochester SurePoint™ registered
IMPULSE MEDICAL TECHNOLOGIES, INC. – The Electrode Store MedCare Visions DPNCheck registered
ALPHATEC SPINE, INC. United States SafeOp SafeOp 3 Arcus General Instruments Sigma registered
Bio Protech, Inc. Present in Europe in other categories United States Bio Protech PROEMG registered
Biomet Orthopedics, LLC Present in Europe in other categories United States ULTRA-DRIVE TOOL Ultra-Drive® Tool ULTRA DRIVE III HANDPIECE ULTRA DRIVE III CONSOLE ULTRA DRIVE IRRIGATION ULTRA-DRIVE® registered
MEDIMAX TECH INC. – MediMax Tech registered
NATUS NEUROLOGY INCORPORATED Present in Europe in other categories United States NATUS NEUROLOGY Natus registered
Temena GmbH United States Temena K990100 (2000)
Ambu A/S Present in Europe in other categories Denmark Neuroline MonopolarNeurology Needle Electrodes Ambu Subdermal CorkscrewSingle Patient Probes Ambu Bipolar ProbeSingle Patient Probes Ambu Monopolar ProbeSingle Patient Probes 202257-000 Needle, Mono Kit Ambu CA CE Ambu Concentric ProbeSingle Patient Probes K071185 (2007)
Kirwan Surgical Products, Inc. United States Kirwan K100912 (2010)
Spineguard S.A. Present in Europe in other categories France PediGuard DSG Connect CANNULATED PEDIGUARD PEDIGUARD CLASSIC PEDIGUARD CURV PEDIGUARD CLASSIC registered
Diopsys, Inc. Present in Europe in other categories United States Diopsys® K101763 (2011)
KOROS U.S.A., INC. United States Dilator Tube Set, Single Use, Sterile Nerve Stimulator Probe Anterior Distraction Screws Neuromonitoring Wire with Clip Disposable XL Dilator Tube Large Dilator Tube registered
Lkc Technologies, Inc. United States RETeval™ UTAS K142567 (2015)
Ad-Tech Medical Instrument Corporation Present in Europe in other categories United States FREMAP Electrode Spinal Electrode Kit K152769 (2016)
STRYKER CORPORATION Present in Europe in other categories United States ES2 SPINAL SYSTEM AVS ARIA K140400 (2014)
Chalgren Enterprises, Inc. United States Chalgren K923665 (1992)
Medos International Sàrl Present in Europe in other categories Switzerland SENTIO registered
Roland Consult Stasche & Finger GmbH Present in Europe in other categories – RETI-port/scan 21 alpha plus RETI-port/scan 21 beta plus RETI-port/scan 21 alpha RETI-port/scan 21 delta plus RETI-port/scan 21 gamma plus RETI-port/scan 21 gamma registered
Checkpoint Surgical, Inc. Present in Europe in other categories United States Guardian Intraoperative Lead, Medium Checkpoint Gemini Checkpoint Head & Neck Guardian Intraoperative Lead, Small Guardian Probe Extension, 12 cm Guardian Probe Extension, 4 cm K212355 (2021)
HAPPY HEALTH, INC. United States Happy Health registered
Impeto Medical Present in Europe in other categories United States SUDOSCAN K141872 (2014)
Watermark Medical, Inc. United States ARES 610 Home Sleep Test Accessories - 10 pack ARES 620 Home Sleep Test Accessories - 10 pack ARES 620 Unicorder System ARES 610 Home Sleep Test Accessories - 50 Pack ARES620 Secure Sleep Test Accessories - 10 pack ARES 610 Unicorder System registered
Wr Medical Electronics Co. Present in Europe in other categories United States Surgical Probe Monopolar Silverstein Facial Nerve Stimulator Remote Probe Hilger Dual Stim Surgical Probe, Monopolar w/Protected Plug Hilger Dual-Stimulator Remote Probe Silverstein Facial Nerve Stimulator K063560 (2007)
Allotrope Medical Inc. United States StimSite K200886 (2020)
NATUS MANUFACTURING LIMITED Present in Europe in other categories Ireland Grass registered
MICROMED SPA Present in Europe in other categories United States Micromed K211974 (2021)
QX WORLD LTD Hungary QUEX S QUEX ED registered
SGM d.o.o. – Corkscrew Electrode Corkscew Electrode registered
XLTEK Canada Natus registered
ASPEN SURGICAL PRODUCTS, INC. Present in Europe in other categories United States Bovie registered
INVOTEC INTERNATIONAL, INC. United States Invotec Single Channel Electrode Invotec Dual Channel Electrode K122040 (2013)
Intelligent Hearing Systems Present in Europe in other categories United States Visual Stimulation Box Universal Smart Box SmartEP Software registered
Kego Corporation Canada KING Disposable Subdermal Corkscrew Needle Electrode registered
Laborie Medical Technologies Canada ULC – Dorado KT Cart with Evox (120V) Aquarius TT with Evox Dorado KT Cart with Evox (240V) registered
Northgate Technologies, Inc. United States StimSite Signal Box StimSite AM-VY1 Adapter StimSite Activation Card registered
R & D Batteries, Inc. United States R&D Batteries, Inc. K933491 (1993)
Ld Technology, LLC Present in Europe in other categories United States ANS1 Software SweatC K152216 (2015)
Lifelines , Ltd. Present in Europe in other categories United Kingdom Lifelines Photic Stimulator K101691 (2010)
METROVISION Present in Europe in other categories France Vision Monitor - MonCvONE Vision Monitor - MonPackONE K212936 (2022)
NEUROSOFT, OOO – Neuro-IOM Focus registered
Neo Medical SA Switzerland NeuroTrace registered
SPINAL ELEMENTS, INC. United States IO-FLEX registered
SpineArt SA Present in Europe in other categories Switzerland OTELO INSTRUMENTATION registered
ANSCHEL TECHNOLOGY INC. United States SightSaverMini K113785 (2012)
BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRKETI – Bioscope Neuromonitor Device registered
Cardinal Health 200, LLC Present in Europe in other categories United States CARDINAL HEALTH registered
Epineuron Technologies Inc. Canada Evala nerve stimulator K253536 (2026)
FREMSLIFE SRL – FREMSLIFE registered
ITOVI, LLC – iTOVi registered
International Health Tech United States BioScan registered
KONAN MEDICAL USA, INC. Present in Europe in other categories Japan – registered
Medeia, Inc. Present in Europe in other categories United States SudoCheck K150804 (2015)
NEUROTRON MEDICAL, INC. United States Brevio K012069 (2001)
Pacira Pharmaceuticals, Inc. United States iovera Smart Tip registered
WITHINGS Present in Europe in other categories France Withings® registered
Zyto Technologies, Inc. United States ZYTO Hand Cradle K111308 (2011)
AD Supply Group Limited United Kingdom – registered
ADM TRONICS UNLIMITED, INC. United States – registered
ALPHATEC HOLDINGS, INC. United States – registered
ARCH Medical Solutions - Olive Branch United States – registered
ARCH Medical Solutions - Seabrook United States – registered
ATL Technology LLC United States – registered
Arch Medical Solutions United States – registered
Ardiem Medical, inc. United States – registered
Arrow International LLC (subsidiary of Teleflex Incorporated Present in Europe in other categories United States – registered
Avalign Delivery Systems Division United States – registered
Avalign Instruments & Implants United States – registered
BEE Medic GmbH Present in Europe in other categories Germany – registered
BEYONICS INTERNATIONAL PTE. LTD. Singapore – registered
BIOSYS BIYOMEDIKAL MUHENDISLIK SANAYI VE TICARET ANONIM SIRK Türkiye – registered
Betts Precision United States – registered
Bionen S.A.S. Present in Europe in other categories United States – registered
Biosys Biyomedikal Muhendislik San. VE Tic. A.S. Türkiye – K233001 (2024)
Bradshaw Medical, Inc. United States – registered
CBR Enterprise Limited Hong Kong SAR China – registered
COMPUMEDICS LIMITED Present in Europe in other categories Australia – registered
Canadian Hospital Specialties Limited Canada – registered
Chemigraphic Ltd United Kingdom – registered
Cirtec Medical Corporation United States – registered
Covidien, LLC Present in Europe in other categories United States – registered
Cryptych Pty, Ltd. Australia – K200705 (2020)
Culver Tool & Engineering LLC dba SpiTrex CTE United States – registered
Daehan Medical Systems Co., Ltd. South Korea – K161566 (2016)
Demcon Production B.V. Netherlands – registered
Ducommun LaBarge Technologies United States – registered
ELMED INCORPORATED United States – registered
EVER PPE INC United States – registered
Engineered Medical Systems United States – registered
Engineering CPR Inc. Canada – registered
Euclide Care France – registered
Exxelia Micropen United States – registered
FIBEROPTICS TECHNOLOGY, INC. United States – registered
FOREFRONT MEDICAL TECHNOLOGY (JIANGSU) CO.,LTD China – registered

The 100 most active manufacturers are shown, out of 181.

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