Bioimaging and radiotherapy instrumentsRadiotherapy and radiosurgery instruments
Brachytherapy radiation instruments
EMDN code Z110103
Manufacturers registered in Europe (EUDAMED) 6
- 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.
| Manufacturer | Country | Registered models | Class | Contact |
|---|---|---|---|---|
| WOLF-Medizintechnik | Germany |
|
IIb MDR, 93/42 | Website info@womed.net EUDAMED record Report an error |
| Varian Medical Systems FDA EU representative : Siemens Healthineers Nederland B.V. (Netherlands) | United States | IIb MDR | EUDAMED record Report an error | |
| BEBIG Medical FDA | Germany | IIb MDR | Website sales@bebigmedical.com EUDAMED record Report an error | |
| CLErmont RAyonnement Détection | France | IIb 93/42 | Website EUDAMED record Report an error | |
| Elekta FDA | Sweden | IIb MDR | EUDAMED record Report an error | |
| OncoBeta | Germany | IIb MDR | Website info@oncobeta.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) 68
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 | K162499 (2018) |
| MICK RADIO NUCLEAR INSTRUMENT, INC | – | MRNI HDR SARCOMA NEEDLE 17G x 28cm MICK TP Needle,18G,25cm,Disp, (25pc) Mick 3mm gold fiduciary marker,17G,single (10pc) Mick 5mm gold fiduciary marker,17G,single (10pc) MICK TP Needle,17G,25cm,Disp, (25pc) MICK 3mm Gold Fiduciary Marker, 17G Single | registered |
| Liberty Medical , Inc. | United States | Flexi-Needle Buttons Medium Prostate Brachytherapy Kit Adapter Intrauterine Tandem Implant Needle | registered |
| Theragenics Corp. | United States | Theragenics SeedLock I-Seed Agx100 TheraSeed TheraMark™ TheraStrand® with I-Seed | 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) |
| CIVCO Medical Instruments Co., Inc. | United States | Cradle Classic Stepper Multi-Purpose Workstation™ Stepper EX3 Stepper Template Grid Micro-Touch® Stabilizer LP | registered |
| Bard Brachytherapy, Inc. | – | BrachyStar™ QuickLink™ BrachyStar™, FastFill™ TheraSeed® BrachySource™ QuickLink™, SourceLink™ | registered |
| 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 |
| 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) |
| ADVANCED RADIATION THERAPY, LLC | United States | AccuBoost AccuBoost® | K062135 (2006) |
| Best Nomos | United States | Reusable Frame, Bard SurePoint Stepper Reusable Frame, CMS AccuSeed Disposable Template, 17 Gauge, Siemens, Single Best Precision Stabilizer Disposable Template, 18 Gauge, Siemens, 5 Pack Reusable Template, Best Precision Stepper, 17 Gauge, Non-Siemens Ultrasound | registered |
| Alpha-Omega Services, Inc. | United States | AOS Interstitial Templates, Needles, and Accesories AOS Universal Connecting Guide Tubes AOS Interstitial Templates, Needles, and Accessories AOS Extension Adaptor AOS Retaining Button (Syed Type), Radiopaque AOS Retaining Button (Syed Type), White Nylon | K233628 (2024) |
| Kobold, LLC | United States | Kobold® Prostate HDR Template - 17 ga/4 Fr Kobold® Fletcher-model Tandem and Cylinder Ovoid Applicator Set (E) Kobold® Prostate HDR Template - 16 ga/5 Fr Kobold® Prostate HDR Stepper Template - 17 ga/4 Fr Kobold® Tandem and 30 Deg Ring Applicator Set (E) Kobold® Vaginal Cylinder Applicator Set (E) | K170203 (2017) |
| Merit Medical Systems, Inc. Present in Europe in other categories | United States | SAVI® | registered |
| Gt Medical Technologies | United States | CS-1 PL-4 PL-3 PL-5 PL-2 PL-4NS | K221539 (2022) |
| Eckert & Ziegler Bebig GmbH Present in Europe in other categories | Germany | Custom AnchorMarker - Gold Marker preloaded in PSS1820SLS Round Hub Needle Preloaded in PSS1820SL3 Square Hub Needles, 3pk Preloaded in PSS1820SL3 Round Hub Needles, Single Pack Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, 3pk Marker Seed - Preloaded in PSS1820SL3 Round Hub Needles, Single Pack Custom MarkerStrand - Two Gold Marker preloaded in PSS1820SLS Round Hub Needle | registered |
| CONCURE ONCOLOGY, INC. | – | BMT Fiducial Needle, Sharp BMT Cleaning Brush Set, Vertical Lock BMT Armrest Armature & Table Clamp BMT Template Grid Armature & Table Clamp BMT Template Grid, Vertical Lock, Large BMT Fiducial Needle, Round | registered |
| 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) |
| ARGON MEDICAL DEVICES, INC. | United States | Prostate Seeding Set Prostate Stabilization Set | registered |
| Sirtex Medical Inc. | United States | SIR-Spheres Delivery Set SIR-Spheres Accessories Pack SIROS Delivery Set SIR-Spheres V-Vial | registered |
| C4 Imaging, LLC | United States | HDR MRI Lumen Marker Sirius MRI Marker Sirius MRI Marker NS | K180069 (2018) |
| CLEAR GUIDE MEDICAL, INC. Present in Europe in other categories | United States | Clear Guide SteriGRID Clear Guide TP Access Posts | registered |
| Civatech Oncology, Inc. | United States | CivaSheet CivaString CivaDerm | K191324 (2019) |
| Cook, Inc. | United States | Cook | K940550 (1994) |
| Icad, Inc. | United States | Cervical Applicator Set Cervical Applicator Set, Bundle 1 Cervical Applicator Set, Bundle 2 | K123442 (2013) |
| Boston Scientific Corp Present in Europe in other categories | United States | TheraSphere™ | registered |
| FUJIFILM Healthcare Americas Corporation Present in Europe in other categories | United States | D&K Technologies | registered |
| AngioDynamics, Inc. | United States | Alatus | registered |
| Hologic, Inc. Present in Europe in other categories | United States | Mammosite Cavity Evaluation Device Kit (CED) | K092405 (2009) |
| RADIADYNE, L.L.C. | United States | Alatus | K092534 (2009) |
| STANDARD IMAGING INC. Present in Europe in other categories | United States | Standard Imaging HDR 1000 Plus | registered |
| B.Braun Medical, Inc. Present in Europe in other categories | United States | – | registered |
| BBF Sterilisationsservice GmbH | Germany | – | registered |
| BEST MEDICAL INTERNA | United States | – | registered |
| BWXT MEDICAL LTD. | Canada | – | registered |
| Biomerics | United States | – | registered |
| Braxx Biotech Co., Ltd. | Taiwan | – | K243045 (2024) |
| C.R. Bard, Inc. | United States | – | K140856 (2014) |
| Contract Medical International, spol. s r.o. | Czechia | – | registered |
| Curium US LLC | United States | – | registered |
| DUPACO, INC. Present in Europe in other categories | United States | – | registered |
| Exact Imaging, Inc. Present in Europe in other categories | Canada | – | registered |
| GEOMED Medizin-Technik GmbH & Co. KG | Germany | – | K201279 (2020) |
| HUESTIS MACHINE CORPORATION | United States | – | registered |
| Hong Kong YanKang Medical Limited | Hong Kong SAR China | – | registered |
| KEYSTONE MANUFACTURING, LLC | United States | – | registered |
| Lv Liberty Vision Corporation | United States | – | K193602 (2020) |
| MTT GmbH Present in Europe in other categories | Germany | – | registered |
| Micro Tool Engineering, Inc. | United States | – | registered |
| Mirion Technologies, Inc. | United States | – | registered |
| Needle Specialty Products | United States | – | registered |
| Nissha Medical Technologies Present in Europe in other categories | United States | – | registered |
| Oncopatch, Inc. | United States | – | K252296 (2025) |
| PAJUNK GmbH Medizintechnologie | Germany | – | registered |
| QSA Global Inc | United States | – | registered |
| Radiance Therapeutics, Inc. | United States | – | K223465 (2023) |
| Radiation Products Design, Inc. | United States | – | registered |
| SYNTHES GMBH / Synthes Produktions GmbH | United States | – | registered |
| 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 |
| Tecma Operaciones S. de R.L. de C.V. | Mexico | – | registered |
| Thermo Fisher Scientific Present in Europe in other categories | United States | – | registered |
| Xeridiem Medical Devices, A Spectrum Plastics Group Company | United States | – | registered |
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