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Emdyca

Bioimaging and radiotherapy instrumentsRadiotherapy and radiosurgery instrumentsBrachytherapy radiation instruments

Brachytherapy radiation systems - consumables

EMDN code Z11010385

2 manufacturers, 42 models including 42 on the market, 1 country

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Manufacturers registered in Europe (EUDAMED) 2
  • 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
Primed Halberstadt Medizintechnik Germany
34 others
IIb MDR, 93/42 Website EUDAMED record Report an error
Bebig FDA Germany I, IIb MDR Website info@bebig.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) 30

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
Best Medical International, Inc. United States Best Medical International K122704 (2013)
Theragenics Corp. United States I-Seed Agx100 Theragenics TheraSeed TheraMark™ TheraStrand® with I-Seed TheraStrand® with TheraSeed® K103319 (2011)
MEDI-PHYSICS, INC. United States OncoSeedTM RAPID STRANDTM I-125 SeedsTM in Carrier RAPID StrandTM Rx RAPID StrandTM Rx MICK Thin SeedTM Iodine-126 K122764 (2012)
RIVERPOINT MEDICAL, LLC United States GOLD MARKER NEEDLE RIVERPOINT BRACHYTHERAPY GOLD FIDUCIAL MARKER FIDUCIAL NEEDLES BRACHYTHERAPY NEEDLE K103449 (2011)
Izi Medical Products, LLC Present in Europe in other categories United States VISICOIL Gold Fiducial VISICOIL MR Twin Line 2PK 0.8X3.0MM GOLD FIDUCIAL LOOSE registered
Bard Brachytherapy, Inc. – TheraSeed® BrachySource™ QuickLink™, SourceLink™ BrachySource™, SourceLink™ TheraSeed®, SourceLink™ SourceLink™ registered
STELLAR MEDICAL, LLC United States Stellar Medical registered
Isoaid, LLC United States Advantage I-125® Advantage Pd-103® Advantage I-125 IsoSphere Advantage-Strand® with Advantage I-125® Advantage-Load® with Advantage Pd-103® K242818 (2025)
Gt Medical Technologies United States CS-1 PL-4 PL-3 PL-5 PL-2 PL-4NS K221539 (2022)
Cp Medical United States FN NEEDLES K071550 (2007)
Eckert & Ziegler Isotope Products, Inc. Present in Europe in other categories – Cs-137 Tube Source registered
Isoray Medical, Inc. United States GliaSite® Catheter Tray GliaSite® Access Tray Iotrex® Cesitrex™ K202267 (2020)
Civatech Oncology, Inc. United States CivaSheet CivaString CivaDerm K191324 (2019)
Varian Medical Systems, Inc. Present in Europe in other categories United States VariSeed VariSeed 9.0 GammaMed Plus GM+ HDR Ir 192 Brachytherapy Sealed Source K150636 (2015)
C4 Imaging, LLC United States Sirius MRI Marker Sirius MRI Marker NS K171487 (2017)
Alpha-Omega Services, Inc. United States AOS Marker Seeds K102811 (2011)
STANDARD IMAGING INC. Present in Europe in other categories United States Standard Imaging HDR 1000 Plus registered
ARGON MEDICAL DEVICES, INC. United States – registered
BEST MEDICAL INTERNA United States – registered
C.R. Bard, Inc. United States – K140856 (2014)
Hologic, Inc. Present in Europe in other categories United States – registered
KEYSTONE MANUFACTURING, LLC United States – registered
Lv Liberty Vision Corporation United States – K193602 (2020)
Micro Tool Engineering, Inc. United States – registered
Oncopatch, Inc. United States – K252296 (2025)
QSA Global Inc United States – registered
Radiance Therapeutics, Inc. United States – K223465 (2023)
Salutaris Medical Devices, Inc. United States – K163206 (2016)
Source Production and Equipment Co., Inc. United States – K162573 (2016)
Straits Orthopaedics (Mfg) Sdn Bhd Malaysia – registered

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