Berkemann Hungary Bt.

Berkemann Hungary Bt. specializes in orthopedic foot supports and bandages designed to address common foot conditions. Their product range includes daytime hallux valgus (bunion) bandages in different sizes and left/right configurations, forefoot spreading bandages (with and without pelottes), toe spacers with fixation, toe supporters, and cross bandages. These devices are intended to provide support, alignment, and comfort for specific foot issues.

Berkemann Hungary Bt. is based in Hungary, which means its devices are manufactured and likely designed under Hungarian regulatory oversight. Since the company’s products are listed in the EUDAMED database, they are intended for the European market and comply with EU medical device regulations. The location does not affect classification but may influence local compliance requirements.

Berkemann Hungary Bt.’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. This registry ensures transparency and traceability of devices marketed within the EU, allowing healthcare professionals, regulators, and patients to verify the manufacturer and device details.

All of Berkemann Hungary Bt.’s devices fall under Class I classification in the EU medical device regulatory framework. This classification applies to low-risk devices like orthopedic supports and bandages, which pose minimal risk to patients when used as intended. Class I devices typically require less stringent conformity assessment procedures compared to higher-risk classes.