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Emdyca

Instruments for functional explorations and therapeutic interventionsNeurology and neurosurgery instrumentsVarious neurology and neurosurgery instruments

Detachable coil equipment for brain aneurysms

EMDN code Z12109001

8 manufacturers, 130 models including 130 on the market, 4 countries

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Manufacturers registered in Europe (EUDAMED) 8
  • 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
Taijieweiye EU representative : Lepu Medical (Europe) Cooperatief U.A. (Netherlands) China
109 others
III 93/42 EUDAMED record Report an error
Balt Usa FDA EU representative : BALT EXTRUSION SAS (France) United States I, IIa, IIb, III 93/42 Website PRRC@baltgroup.com EUDAMED record Report an error
Micro Therapeutics D B A Ev3 Neurovascular FDA EU representative : Medtronic B.V. (Netherlands) United States I, IIa MDR EUDAMED record Report an error
Swlmed Germany III MDR Website EUDAMED record Report an error
Cerenovus FDA EU representative : DePuy Ireland UC (Ireland) United States I, IIa MDR Website EUDAMED_Enquiries@its.jnj.com EUDAMED record Report an error
Kaneka FDA EU representative : Kaneka Medical Europe N.V. (Belgium) Japan IIb MDR, 93/42 Website EUDAMED record Report an error
Shapemem FDA EU representative : MedR-AR Services B.V. (Netherlands) United States IIa 93/42 info@shapemem.com EUDAMED record Report an error
Wallaby Medical FDA EU representative : Emergo Europe B.V. (Netherlands) United States III MDR 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) 62

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
Micro Therapeutics, Inc. United States Axium™ Detachable Coil System Axium™ Prime Detachable Coil System AxiumTM Axium Prime Detachable Coil System Axium Detachable Coil System Axium PrimeTM K090046 (2009)
MicroVention, Inc. United States V-Trak HydroSoft Helical MicroPlex Helical Soft HydroFill Helical HydroCoil Helical MicroPlex Helical Regular K223050 (2022)
Penumbra, Inc. United States Penumbra Coil 400 LP Coil System RUBY Coil Swift Coil System POD POD Packing K250079 (2025)
MicroPort NeuroTech (Shanghai) Co., Ltd. China Numen Numen Helia NumenFR K260351 (2026)
STRYKER CORPORATION Present in Europe in other categories United States GDC-10 TARGET GDC-18 TARGET XL Target Tetra K120816 (2012)
Shanghai Wallaby Medical Technologies Co., Inc. – Avenir Avenir Mega Coil System registered
Cook, Inc. United States Hilal MReye Tornado Nester MicroNester Retracta K160219 (2016)
Boston Scientific Corp Present in Europe in other categories United States Bead Block™ LC Bead 100-300 LC Bead M1 70-150 Bead Block 700-900 LC Bead 300-500 Bead Block 900-1200 K261488 (2026)
Medos International Sàrl Present in Europe in other categories Switzerland ORBIT GALAXY ORBIT GALAXY XTRASOFT K220040 (2022)
Biosphere Medical, S.A. Present in Europe in other categories France Embosphere® QuadraSphere® QuadraSphere Q2™ EmboGold® EmboCube® Torpedo™ K250971 (2025)
Medtronic, Inc. Present in Europe in other categories United States Concerto Versa™ MVP™ MVP® Intersept® K261866 (2026)
Celonova Biosciences, Inc. United States Embozene Microspheres (Color-Advanced) Embozene Microspheres (Opaque) ONCOZENE Microspheres K141209 (2014)
Canyon Medical, Inc. Present in Europe in other categories China Polyvinyl Alcohol Embolic Microspheres K250209 (2025)
Varian Medical Systems, Inc. Present in Europe in other categories United States ONCOZENE 40um Oncozene 3mL - US Embozene Color Advance 1300um Embozene 1mL Colored - US Embozene Color Advance 900um Embozene 1mL Colored - US Embozene Color Advance 40um Embozene 1mL Colored - US Embozene Color Advance 1300um Embozene 2mL Colored - US Embozene Color Advance 700um Embozene 1mL Colored - US K242608 (2025)
Aga Medical Corp. United States AMPLATZER™ K113658 (2012)
TELEFLEX INCORPORATED Present in Europe in other categories United States OPTISPHERE GEL-BEAD GEL-BLOCK registered
Nuvascular, Inc. United States HARBOR K260635 (2026)
William Cook Europe ApS Denmark MReye Flipper Flipper registered
Merit Medical Systems, Inc. Present in Europe in other categories United States Bearing nsPVA® SIEGE™ K240261 (2024)
Vascular Solutions, Inc. Present in Europe in other categories United States Gel-Bead™ Embolization Spheres K173891 (2018)
Artio Medical, Inc United States Solus Gold™ Embolization Device K213200 (2022)
IMBiotechnologies Ltd United States Occlusin 500 K093813 (2010)
Abk Biomedical, Inc. Canada Easi-Vue embolic microspheres System K234123 (2024)
Okami Medical United States LOBO K262798 (2026)
Artventive Medical Group, Inc. United States ArtVentive Endoluminal Occlusion System (EOS) K212057 (2022)
Embolization Inc. United States Nitinol Enhanced Device K250276 (2025)
KA MEDICAL LLC United States Micro Plug Set K182944 (2019)
St Jude Medical United States Amplatzer™ registered
Biocompatibles UK Limited United States LC Bead 500-700 K162373 (2016)
EMBOLIC ACCELERATION, LLC United States Hourglass Peripheral Embolization Device EMBA Hourglass Peripheral Embolization Device K200083 (2020)
Reverse Medical Corporation United States – K150108 (2015)
ATRION CORP. United States – registered
Abbott Laboratories Present in Europe in other categories United States – registered
Amphenol Alden Products Company United States – registered
Ates Medical S.R.L. United States – registered
BENCHMARK ELECTRONICS, INC. United States – registered
Bait USA, LLC United States – K220699 (2022)
Blockade Medical, LLC (D.B.A. Balt Usa) United States – K172390 (2018)
Boulder BioMed dba Boulder iQ United States – registered
Boulder iQ United States – registered
C.R. Bard, Inc. United States – K191532 (2020)
Cardimed Asia Medikal Sanayi ve Ticaret Ltd Sti Türkiye – registered
Codman & Shurtleff, Inc. United States – K171862 (2017)
Covidien, LLC Present in Europe in other categories United States – registered
DSV Contract Logistics Mexico – registered
Emba Medical Limited United States – K171845 (2017)
Hangzhou Yangshun Medical Technology Co.,Ltd China – K232934 (2024)
Instylla, Inc. United States – K253677 (2025)
Jabil Inc. United States – registered
Kaneka Medical America, LLC Present in Europe in other categories United States – K210638 (2021)
Lake Region Medical United States – registered
MURRAY, INC. United States – registered
Merit Medical System, Inc. Present in Europe in other categories United States – K212817 (2021)
Micro Therapeutics Lnc. D/B/A Ev3 Neurovascular United States – K233420 (2023)
Obsidio, Inc. United States – K213385 (2022)
SCIENTIFIC MOLDING CORPORATION, LTD United States – registered
Spartan Micro, Inc. United States – K180653 (2018)
Stryker Neurovascular United States – K252694 (2025)
Stryker Neurovscular United States – K261772 (2026)
Suzhou Haowei Medical Technology Co., Ltd. China – K252812 (2026)
Suzhou Hengrui Hongyuan Medical Co., Ltd. Present in Europe in other categories China – K210562 (2021)
Terumo Medical Corp. Present in Europe in other categories United States – registered

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