Horizons International Corp.

Horizons International Corp. specializes in single-use airway management devices. Their portfolio includes supraglottic airway devices (such as the HIC-SNG-22 and HIC-CB-22 series), supraglottic intubators (e.g., HIC-SI-23), and bronchoscopy tools like the ANSO® Transbronchial Needle and TWISTER® PLUS biopsy forceps. These devices are designed for procedural and emergency airway interventions, as well as diagnostic and therapeutic bronchoscopy.

Horizons International Corp. is based in Costa Rica. Their devices are regulated under Costa Rican medical device standards, and they also comply with EU Medical Device Regulations, where applicable. The company’s products are listed in the EU’s eudamed database, indicating their registration under EU requirements.

Horizons International Corp.’s devices are listed in the eudamed database, which is the EU’s central registry for medical devices. This listing confirms their registration under EU Medical Device Regulations, though individual devices must still meet their respective classification requirements for market authorization.

Under the EU Medical Device Regulations, Horizons International Corp.’s devices fall into Class I and Class IIa classifications. Classification determines the regulatory pathway for market authorization, with Class IIa requiring additional scrutiny (e.g., clinical evaluation) compared to Class I. The specific classification depends on the device’s intended use and risk profile, as outlined in EU MDR Annex VIII.