Instrumentaria d.d.

Instrumentaria d.d. specializes in reusable instrument trays and containers primarily for orthopaedic and traumatology applications. These include containers designed to hold specific instrument sets like Zweymüller sets, as well as trays for cannulated screws (various sizes), locking screws (e.g., 2.5, 4.5, and 5.5 mm), fragment screws, and IKO instruments. Some containers are also sized for sterilization purposes, such as the 160x80x40 mm model. The focus is on organizing and protecting surgical tools for orthopaedic procedures.

Instrumentaria d.d. is based in Croatia (HR), a European country. While the company’s exact market reach isn’t specified, its products are designed for global distribution, as mentioned in its description. The devices are listed in the EUDAMED registry, indicating compliance with EU regulatory requirements, though this does not limit their potential use outside the EU.

Instrumentaria d.d.’s devices are listed in the EUDAMED registry, which is the European database for medical devices. This registry tracks devices authorized under EU regulations, such as those classified under the Medical Device Regulation (MDR) or Medical Device Directive (MDD). Listing in EUDAMED confirms the devices meet EU requirements for classification and compliance, though it does not imply approval for markets outside the EU.

All of Instrumentaria d.d.’s listed devices fall under EU Class I, the lowest risk category for medical devices. This classification applies to items like reusable instrument trays and containers that do not pose significant health risks when used as intended. Class I devices typically require less stringent regulatory oversight compared to higher-risk classes (e.g., Class IIa, IIb, or III), but they still must comply with EU safety and performance standards before being placed on the market.