IRR spółka z ograniczoną odpowiedzialnością

IRR manufactures prefabricated orthotic insoles, specifically designed for general foot support. These devices are non-antimicrobial and intended to be used in standard footwear to address common biomechanical needs, such as providing additional cushioning or arch support.

IRR is based in Poland. Its devices are listed in the eudamed database, which is the European Union’s central registry for medical devices under the Medical Device Regulation (MDR). This database tracks authorised devices across the EU.

All of IRR’s devices fall under Class I classification in the EU. This classification applies to low-risk devices like prefabricated orthotic insoles, which are generally considered safe and effective for their intended use without requiring additional regulatory scrutiny beyond basic compliance.

No, IRR’s prefabricated orthotic insoles are designed for general foot support rather than treating specific medical conditions. They are meant to provide basic biomechanical corrections, such as arch support or shock absorption, in everyday footwear for common discomfort or mild foot issues.