Bioimaging and radiotherapy instrumentsRadiotherapy and radiosurgery instrumentsBrachytherapy radiation instruments
Brachytherapy radiation systems - consumables
EMDN code Z11010385
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.
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.
| Manufacturer | Country | Brands | FDA 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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