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Emdyca

Instruments for functional explorations and therapeutic interventionsGeneral and multidisciplinary surgery instruments

Instruments for ultrasonic surgery

EMDN code Z120108

17 manufacturers, 47 models including 47 on the market, 6 countries

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Manufacturers registered in Europe (EUDAMED) 17
  • 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
SRA Developments FDA EU representative : BOWA-electronic GmbH (Germany) United Kingdom (ex Northern Ireland)
6 others
IIb 93/42 Website EUDAMED record Report an error
Kafgrup Türkiye
2 others
IIb 93/42 Website info@kafgrup.com EUDAMED record Report an error
Innolcon EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR EUDAMED record Report an error
Miconvey FDA EU representative : SUNGO Europe B.V. (Netherlands) China IIb MDR EUDAMED record Report an error
Kirmed International Italy IIb MDR info@kirmedinternational.com EUDAMED record Report an error
Surgnova FDA EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR qara@surgnova.com EUDAMED record Report an error
LHbiomed FDA EU representative : TECHNOLUX Srl (Italy) South Korea IIb 93/42 Website EUDAMED record Report an error
Mectron FDA Italy IIa MDR Website EUDAMED record Report an error
Surgsci EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR ra@surgsci.com EUDAMED record Report an error
Affacare EU representative : Prolinx GmbH (Germany) China IIb 93/42 EUDAMED record Report an error
B.J.ZH.F.Panther Medical Equipment FDA EU representative : Obelis s.a. (Belgium) China IIb MDR Website ra@pantherhealthcare.com EUDAMED record Report an error
Beneeon (Jiangsu) Medical Technology EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR sales@bnycmed.com EUDAMED record Report an error
Edgemed EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR EUDAMED record Report an error
J. Morita Mfg FDA EU representative : Medical Technology Promedt Consulting GmbH (Germany) Japan IIa 93/42 Website EUDAMED record Report an error
Newpong FDA EU representative : Emergo Europe B.V. (Netherlands) South Korea IIb 93/42 info@newpong.com EUDAMED record Report an error
Ningbo Hitcm Medical Devices EU representative : Shanghai International Holding Corp. GmbH(Europe) (Germany) China IIb MDR EUDAMED record Report an error
Zerone EU representative : CMC Medical Devices & Drugs SL (Spain) South Korea IIb 93/42 Website 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) 88

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
Misonix, Inc. United States SonaStar neXus BoneScalpel SonicOne O.R. SonicOne Clinic SonicOne (O.R. & Clinic) K261448 (2026)
Orthosonics, Ltd. United Kingdom OSCAR K093805 (2010)
SMTP Medical Co., Ltd. China SMTP registered
Satelec United States ACTEON SATELEC K100410 (2010)
RADLEY SCIENTIFIC LIMITED Present in Europe in other categories United Kingdom TORS registered
W & H Dentalwerk Bürmoos GmbH Present in Europe in other categories Austria Piezomed Pro Accessory Piezomed Pro M-PH350 Piezomed Pro M-PM100 registered
Peter Brasseler Holdings, LLC United States Axiom Blades Axiom Accessories Axiom Handle Axiom Kit Axiom Generator registered
Biomet Orthopedics, LLC Present in Europe in other categories United States Ultra-Drive® Tool ULTRA-DRIVE TOOL ULTRA-DRIVE® ULTRA DRIVE III HANDPIECE ULTRA DRIVE III CONSOLE ULTRA DRIVE IRRIGATION registered
Karl Storz GmbH & Co. KG Present in Europe in other categories Germany n.a. CALCUSON registered
E.M.S Electro Medical Systems S.A Present in Europe in other categories United States LITHOCLAST K230893 (2023)
Arobella Medical, LLC United States Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 1 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 4 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 14 Qoustic Wound Therapy System®, Qoustic Qurette® Probe, Type 6 Qoustic Choice® Wound Therapy System Ultrasonic Generator Qoustic Choice® Wound Therapy System, Disposable Tubing Set K062544 (2007)
Tendonova Corporation United States TendoNova Ocelot Ocelot K212049 (2022)
Hunan Handlike Minimally Invasive Surgery Co., Ltd. China Handlike K233036 (2024)
STRYKER MEDTECH K.K. – Hyper LT Sonopet registered
TRICE MEDICAL, INC. United States Tenex 2nd Generation MicroTip, TXL+, 2.5 WL Tenex 2nd Generation MicroTip, TXS+, 1.3 WL Tenex 2nd Generation Fuse Set Tenex 2nd Generation Console Tenex 2nd Generation MicroTip, TXS, 2.0 WL Tenex 2nd Generation MicroTip, TXL, 3.0 WL K241700 (2024)
Söring GmbH – UAW Instrument SONOCA 185 registered
Kirwan Surgical Products, Inc. United States Kirwan K070360 (2007)
STRYKER SUSTAINABILITY SOLUTIONS, INC. United States – registered
DEPUY SPINE, LLC United States HARMONIC OSTEOVUE registered
AD Supply Group Limited United Kingdom – registered
Aesculap, Inc. Present in Europe in other categories United States – registered
Automatics Tooling Company Ltd United Kingdom – registered
BENCHMARK ELECTRONICS, INC. United States – registered
BRDH Netherlands – registered
BURAK GLOBAL IC VE DIS TIC LTD STI Türkiye – registered
Bioventus LLC Present in Europe in other categories United States – registered
CADEX ELECTRONICS, INC. Canada – registered
CBR Enterprise Limited Hong Kong SAR China – registered
Carl Zeiss Meditec, AG Present in Europe in other categories United States – K261361 (2026)
Cybersonics, Inc. United States – K171024 (2017)
Diafarma Ecza Deposu ve Medikal Dis Ticaret Dis Tic Ltd Sti Türkiye – registered
Electro Medical Systems SA United States – registered
Ethicon Endo-Suregery, LLC United States – K160752 (2016)
Eurofins inpac Medizintechnik GmbH Germany – registered
Foreasytech S.r.l. Italy – registered
Frueh Verpackungstechnik AG Switzerland – registered
GREATBATCH MEDICAL United States – registered
ITD GmbH Present in Europe in other categories Germany – registered
Intl. Medical Technologies, Inc. United States – registered
Intuitive Surgical, Inc. Present in Europe in other categories United States – registered
Jabil Inc. United States – registered
KATALYST SURGICAL LLC United States – K192963 (2020)
Linemaster Switch Corp. United States – registered
MAVERA TIBBI CIHAZLAR ANONIM SIRKETI Türkiye – registered
MDTGlobal, a.s. Slovakia – registered
MEDI.PLAN GmbH & Co. KG Germany – registered
MEDLINE INDUSTRIES, INC. Present in Europe in other categories United States – registered
MIING WEI CO., LTD. Taiwan – registered
MKA MEDIKAL IC VE DIS TICARET SANAYI LIMITED SIRKETI Türkiye – registered
MOOG, INC. United States – registered
Medineedle - Rescue Group Rettungsdienst Germany – registered
Medisonic Technology CO United States – K190281 (2019)
Medtronic, Inc. Present in Europe in other categories United States – registered
Misonix, LLC, A Bioventus Company United States – K231117 (2023)
Modo Inc United States – registered
Morley Research Consortium United States – K172464 (2018)
NAS MED LLC FZ United Arab Emirates – registered
Nissha Medical Technologies Present in Europe in other categories United States – registered
ORTA MEDICAL LTD Israel – registered
PLEXUS CORP. United States – registered
PMC SMART Solutions United States – registered
Precera Medical Inc United States – registered
Primo Medical Group, Inc United States – registered
Promepla Present in Europe in other categories Monaco – registered
R.H. CROSS ENTERPRISES, INC. United States – registered
Remington Medical, Inc. United States – registered
Richard Wolf GmbH Present in Europe in other categories Germany – registered
Robling Medical, LLC United States – registered
SANMED MEDIKAL OTOMOTIV TEKSTIL TICARET LIMITED SIRKETI Türkiye – registered
SIMAGEC France – registered
Sanicure BV Netherlands – registered
Satalec-Acteon Group France – K163610 (2017)
Satelec - Acteon Group United States – registered
Shenzhen Codyson Electrical Co, Ltd Present in Europe in other categories China – registered
Shenzhen Perfect Idea Technology Limited China – registered
Single Source Medical LLC United States – registered
Smtp Technology Co., Ltd. China – K201274 (2021)
Soering GmbH United States – K072904 (2008)
Spectrum Plastics Group United States – registered
Summit Medical , Ltd. Present in Europe in other categories United Kingdom – registered
TECOMET INC. United States – registered
TOUCHBEAUTY BEAUTY & HEALTH (SHENZHEN) CO., LTD China – registered
Vesta United States – registered
W&H Dentalwerk Buermoos GmbH Austria – registered
W&H Impex Inc. Canada – registered
Zimmer Biomet APAC DFE China – registered
Zimmer, Inc. Present in Europe in other categories United States – registered
ZimmerBiomet Americas DFE United States – registered

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