AUG MEDICAL Spółka z ograniczoną odpowiedzialnością

AUG MEDICAL primarily manufactures reusable laryngoscope blades, single-use anaesthesia face masks, and manual pulmonary resuscitators. Additionally, it produces diagnostic tools like ophthalmic and otologic diagnostic sets, otoscopes, ophthalmoscopes, ENT diagnostic sets, and air cushion masks. These devices are designed for airway management, resuscitation, and medical examinations.

AUG MEDICAL Spółka z ograniczoną odpowiedzialnością is based in Poland. The company’s location in Poland influences its regulatory compliance, particularly for devices marketed within the European Union.

AUG MEDICAL’s devices are listed in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registry ensures transparency and traceability of devices authorised under EU regulations.

All of AUG MEDICAL’s devices fall under EU Class I classification. This classification applies to low-risk devices like diagnostic sets, otoscopes, and reusable blades, which typically require less stringent regulatory oversight compared to higher-risk categories.

Even though Class I devices are generally considered low-risk, EU regulations mandate their registration in EUDAMED to ensure compliance with the EU Medical Device Regulation (MDR) or Medical Device Directive (MDD). This registry helps healthcare professionals, authorities, and patients verify the legitimacy of the manufacturer and device details, maintaining transparency in the supply chain.