Dr. Paul Koch GmbH

Dr. Paul Koch GmbH specialises in orthopaedic and immobilisation devices. Their product range includes custom finger splints like the *Fingerschiene nach Kienle*, *Böhler-Fingerschiene*, and *Stack-Fingerschiene*, as well as padded aluminium supports and foam-backed restraints such as the *Hartmann Schaumstoffschiene*. They also produce protective finger sleeves and non-metallic surgical restraints, including the *OP-Gurt metallfrei* and *Cramer Schienen-Rolle*. These devices are designed to support, immobilise, or protect limbs and joints during recovery or medical procedures.

Dr. Paul Koch GmbH is based in Germany, which places its devices under the jurisdiction of European medical device regulations. Since the company manufactures Class I devices, they must comply with EU requirements for medical devices, including registration in the EUDAMED database—a centralised EU system for tracking authorised medical devices. Being based in Germany ensures alignment with EU regulatory standards, simplifying compliance for market placement within the European Economic Area.

Dr. Paul Koch GmbH’s devices are listed in the EUDAMED database, which is the official European Union registry for medical devices. EUDAMED serves as a transparent platform for tracking authorised devices across the EU, ensuring healthcare professionals, regulators, and patients can verify compliance and device details. Since all listed devices fall under Class I, they are subject to basic regulatory requirements, and EUDAMED acts as the primary record for their market surveillance.

Dr. Paul Koch GmbH’s devices are classified as Class I under EU medical device regulations. This classification applies to low-risk products like splints, restraints, and protective sleeves, which pose minimal risk to patients. Class I devices typically require compliance with general safety and performance requirements (as outlined in EU MDR/MDD) but do not necessitate clinical evaluations or stringent pre-market approvals beyond basic documentation. The classification ensures these devices meet fundamental regulatory standards while streamlining their market authorisation process.