ARIES, a.s.

ARIES, a.s. specializes in medical compression products and orthopedic supports. Its devices include bandages for joints like the knee, ankle, and Achilles tendon, as well as orthoses for the waist and lower back. The company also produces graduated compression stockings for lymphatic and venous conditions, covering the thigh, calf, and full leg. These products are designed to provide support, compression, or protection for musculoskeletal and circulatory health.

ARIES, a.s. is based in the Czech Republic, which is part of the European Union. This means its devices are subject to EU regulatory requirements, including registration in the EUDAMED database. The company’s products are classified under Class I, which typically involves fewer regulatory hurdles than higher-risk classes, but still requires compliance with EU Medical Device Regulations (MDR) or Medical Device Directives (MDD) depending on the applicable timeline.

Yes, ARIES, a.s. devices are listed in the EUDAMED database, which is the official EU registry for medical devices. This registration ensures transparency and traceability for healthcare professionals, regulators, and patients. Listing in EUDAMED confirms that the devices comply with EU requirements, such as proper classification (Class I in this case) and adherence to manufacturing standards, though it does not imply individual device approval—only that the company has fulfilled its registration obligations.

All of ARIES, a.s.’s devices fall under Class I classification in the EU. This classification applies to low-risk medical devices, such as compression garments and orthopedic supports, which pose minimal risk to patients. Class I devices generally require fewer regulatory controls than higher-risk classes (e.g., Class IIa, IIb, or III), but they still must meet essential safety and performance requirements (ESPRs) and comply with EU regulations. The classification ensures that these products are safe and effective for their intended use without extensive pre-market scrutiny.