# Technomed Europe

- Location (FDA's records): Maastricht-Airport, NL
- FDA decisions: 13 (1999–2026): 13 510(k) clearances
- Product codes: GXZ (4), IKT (3), GXY (3), ETN (2), GXI (1)
- Predicates its devices cite: 39 (6 its own); citations of its devices by later devices: 28 (6 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Chalgren Enterprises, Inc.: 6 (https://510kreport.com/company/chalgren-enterprises)
- The Magstim Company, Ltd.: 4 (https://510kreport.com/company/magstim)
- Radionics, Inc.: 3 (https://510kreport.com/company/radionics)
- Cadwell Laboratories, Inc.: 2 (https://510kreport.com/company/cadwell-laboratories)
- Medelec, Inc. D.B.A. Teca Corp.: 2 (https://510kreport.com/company/medelec-dba-teca)
- Specialized Laboratory Equipment, Ltd.: 1 (https://510kreport.com/company/specialized-laboratory-equipment)
- Medicotest A/S: 1 (https://510kreport.com/company/medicotest-a-s)
- Medelec Intl. Corp.: 1 (https://510kreport.com/company/medelec-intl)

## Firms that cite its devices most
- Cosman Medical, Inc.: 3 (https://510kreport.com/company/cosman-medical)
- Cadwell Lab, Inc.: 2 (https://510kreport.com/company/cadwell-lab)
- Spes Medica Srl: 2 (https://510kreport.com/company/spes-medica)
- Daehan Medical Systems Co., Ltd.: 2 (https://510kreport.com/company/daehan-medical-systems)
- Axon Systems, Inc.: 2 (https://510kreport.com/company/axon-systems)
- Isurgical: 1 (https://510kreport.com/company/isurgical)
- Dymedix Diagnostics, Inc.: 1 (https://510kreport.com/company/dymedix-diagnostics)
- Coapt, LLC: 1 (https://510kreport.com/company/coapt)

## Its most-cited devices
- K990015: Electrode Needles (1999), cited by 5
- K042375: SMK, CX, Cxe, RCN (2004), cited by 4
- K072016: Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable (2007), cited by 4
- K050325: Disposable Concentric Probe, Disposable Bipolar Probe, Disposable Monopolar Probe (2005), cited by 4
- K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, (2013), cited by 3
- K062437: Disposable Hypodermic Emg Needle Electrode Technomed Europe Version and Private Labeled (2007), cited by 3

## Recent decisions
- K254183: MR Conditional Cup Electrodes (May 7, 2026)
- K253581: Disposable Concentric Needle Electrode 0.30x25mm Red (TE/B50700-001); Disposable Concentric Needle Electrode 0.40x25mm Yellow (TE/B50700-002); Disposable Concentric Needle Electrode 0.30x30mm Pink (TE/B50700-006); Disposable Concentric Needle Electrode 0.45x37mm Green (TE/B50700-003); Disposable Concentric Needle Electrode 0.45x50mm Blue (TE/B50700-004); Disposable Concentric Needle Electrode 0.60x75mm Violet (TE/B50700-005) (Mar 15, 2026)
- K241045: Disposable Subdermal Needle Electrode, Corkscrew (Dec 11, 2024)
- K130136: Disposable and Reusable Concentric Needle Electrodes,Disposable and Reusable Subdermal Needle Electrodes, (Jul 19, 2013)
- K121257: Laryngeal Electrode (Aug 28, 2012)
- K110422: Surgical Stimulators (May 26, 2011)
- K073532: Disposable Adhesive Surface Electrodes, Disc Electrodes (May 1, 2008)
- K072016: Cup Electrodes, Gold, Reusable, Silver, Reusable; Cup Electrodes Silver/Silver Chloride Reusable (Oct 19, 2007)

Source page: https://510kreport.com/company/technomed-europe