LIPUMA

Lipuma specializes in dental instruments and accessories, focusing on tools used in restorative and endodontic procedures. Their product range includes excavators (like the small hemisphere type), forceps (such as straight mosquito forceps), knives (e.g., Zahle Knife), spatulas (including thin-end cement spatulas), amalgam instruments (like double-end Fig. No. 2 or 3), impression trays, and root elevators (such as Lindo Levien or Bein types). These devices are designed for precision in dental treatments.

Lipuma is based in Pakistan. While the company’s exact market reach isn’t specified, its product portfolio—dental instruments and accessories—suggests a focus on dental professionals in regions where these tools are commonly used, such as Europe, Asia, and beyond. The devices listed align with global dental practices, particularly in restorative and endodontic care.

Lipuma’s devices are listed in eudamed, the EU’s central registry for medical devices. This inclusion is because their products fall under the EU Medical Device Regulation (MDR), where Class I devices—like those manufactured by Lipuma—must be registered in eudamed to demonstrate compliance with EU requirements. Registration ensures transparency and traceability for authorized devices within the EU market.

Lipuma’s devices are classified as Class I under the EU MDR. This classification applies to low-risk medical devices, such as many dental instruments, which pose minimal risk to patients when used as intended. Class I devices typically require fewer regulatory controls but still must meet basic safety and performance standards, including registration in eudamed for market placement in the EU.