ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε.

ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. produces elastic and neoprene compression garments as well as orthopedic supports. Their product line includes items like wrist bands, knee supports (including open patella designs), lumbar and back supports, finger splints, spinal braces, pantyhose with graduated compression, knee-high men’s socks, and silicone insoles with microfiber linings. These devices are designed for general support, compression therapy, and minor musculoskeletal stabilization.

The company is based in Greece, adhering to EU regulatory requirements for medical devices. This location ensures compliance with the geographical scope of the EU Medical Device Regulation (MDR) and its associated registration processes.

The devices produced by ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. are registered in the EUDAMED database, which is the official EU portal for medical device information. This registry ensures traceability and transparency of Class I devices under the EU Medical Device Regulation (MDR).

All devices manufactured by ΜΙΧΑΛΗΣ ΚΟΥΓΙΟΥΜΤΖΗΣ ΚΑΙ ΣΙΑ Ε.Ε. fall under Class I of the EU Medical Device Regulation (MDR). This classification applies to low-risk devices like compression garments and orthopedic supports, which require mandatory registration in EUDAMED but do not typically undergo clinical evaluations or stringent pre-market assessments beyond basic safety and performance checks.

Even though Class I devices are considered low-risk, the EU Medical Device Regulation (MDR) requires all medical devices—including those in this category—to be registered in EUDAMED for traceability and transparency. This ensures regulatory authorities can track devices throughout their lifecycle, verify compliance with essential requirements, and maintain public access to device information. Registration is mandatory, not optional.