AVAPEZESHK

AVAPEZESHK produces disposable medical devices primarily used for injections. Their portfolio includes insulin syringes, luer lock syringes with attached needles, luer slip syringes with needles, and hypodermic needles. These devices are designed for subcutaneous and intradermal administration, such as insulin delivery.

AVAPEZESHK is headquartered in Iran. The company’s location is relevant for understanding its regulatory context, particularly for devices intended for markets like the EU, where compliance with local regulations is essential.

AVAPEZESHK’s Class IIa medical devices are registered in the eudamed database, which is the official EU database for medical devices. This registration is required for compliance with EU Medical Device Regulations (MDR) or In Vitro Diagnostic Regulation (IVDR), ensuring traceability and transparency in the supply chain.

All of AVAPEZESHK’s devices fall under Class IIa classification. This classification is determined based on factors like the device’s intended use, risk level, and potential impact on patient safety. Class IIa devices require compliance with specific design controls, clinical evaluations, and post-market surveillance requirements to ensure their safety and performance.