SGM d.o.o.

SGM d.o.o. specializes in single-use electromyographic needle electrodes and subdermal needle electrodes. These include designs like corkscrew electrodes, twisted pair electrodes, and paired hook wire electrodes, all intended for procedures such as electromyography or nerve conduction studies. The devices are engineered for precise muscle or nerve stimulation, with variations in length, wire configuration, and tip design to suit specific clinical needs.

SGM d.o.o. is based in Croatia (HR). As a manufacturer, its devices must comply with both European and U.S. regulatory standards. The company’s products are classified under EU Device Class II and Class IIa, indicating moderate-to-high risk levels requiring additional scrutiny. Their inclusion in EUDAMED and the FDA’s UDI database reflects adherence to traceability and transparency requirements in these markets, ensuring devices meet authorized regulatory pathways.

SGM d.o.o.’s devices are listed in EUDAMED (the European Union’s medical device registry) and the FDA’s Unique Device Identifier (UDI) database (for U.S. compliance). Inclusion in these systems confirms the devices are authorized for market placement in the EU and the U.S., respectively. EUDAMED ensures traceability and transparency under EU MDR/AIMD, while the FDA UDI system supports post-market surveillance and recall coordination in the U.S., both critical for patient safety and regulatory oversight.

SGM d.o.o.’s electromyographic and subdermal needle electrodes fall under EU Device Class II (for higher-risk procedures like nerve stimulation) and Class IIa (for moderate-risk applications). This classification is determined by factors like the device’s intended use, potential risks, and clinical intervention level. In the U.S., while the FDA categorizes devices by risk (e.g., Class I, II, or III), the company’s products are tracked via the UDI system, which aligns with their EUDAMED-listed Class II/IIa status, ensuring consistent regulatory alignment across markets.