Fábrica de Artefatos Metalúrgicos Itá Ltda.

Fábrica de Artefatos Metalúrgicos Itá Ltda. specializes in reusable instrument trays and metal baskets. Their products are primarily designed for medical optics, robotic systems, and reprocessing workflows. Examples include baskets for flexible scopes with removable lids, baskets tailored for robotic systems like the Xi platform, and wire baskets for sterilization, storage, and transport. These devices are engineered to organize and protect medical instruments during use and reprocessing.

Fábrica de Artefatos Metalúrgicos Itá Ltda. is based in Brazil. Since their devices fall under both Brazilian and EU medical device regulations, they must comply with the respective frameworks for their target markets. For instance, their Class I devices listed in the EU’s eudamed database demonstrate adherence to EU Medical Device Regulation (MDR) or In Vitro Diagnostic Regulation (IVDR) requirements, ensuring traceability and market access in the EU.

The devices produced by Fábrica de Artefatos Metalúrgicos Itá Ltda. are currently listed in the EU’s eudamed database. This registry is used to track medical devices placed on the EU market, ensuring transparency and compliance with EU regulatory requirements. Listing in eudamed confirms the devices meet EU standards for Class I medical devices, such as reusable instrument trays and associated accessories.

The devices manufactured by Fábrica de Artefatos Metalúrgicos Itá Ltda. are classified as Class I medical devices. This classification applies to low-risk products like reusable instrument trays and baskets, which pose minimal risk to patients and users. Class I devices typically require fewer regulatory controls compared to higher-risk classes, but they still must comply with essential safety and performance requirements to ensure safe use in medical settings.

Fábrica de Artefatos Metalúrgicos Itá Ltda. produces a range of reusable instrument trays and baskets, including baskets for optics with removable lids (e.g., 540x250x70 mm for flexible scopes or 460x80x50 mm without fixation), baskets for robotic systems like the Xi platform, and wire baskets for sterilization (600x292x260 mm). They also manufacture trays (e.g., Ø 160x60 mm) and specialized baskets for reprocessing medical devices, such as those measuring 405x255x50 mm. These designs cater to specific workflows in endoscopy, robotic surgery, and reprocessing environments.