L.M. MEDICAL DIVISION S.R.L.

L.M. Medical Division S.R.L. specializes in tissue specimen x-ray systems intended for in vitro diagnostics (IVD), such as the CIGNO OP-PND1. Their portfolio also includes medical beds and accessories—like the SUPPLY BED HEAD SIMPLE and LIFE V-LINE—for patient positioning and care in operating rooms, hospitals, and intensive care units. Additionally, they produce respiratory support devices (e.g., LINDE SIMPLE) and patient mobility aids (e.g., INDEPENDANT CARE BASIC ES). These devices are designed for clinical environments where precise patient management and diagnostic support are critical.

L.M. Medical Division S.R.L. is based in Italy, which places its devices under EU medical device regulations. Since the company manufactures products like the OPTIMA ASTRA W and LINDE VIP-I, these must comply with EU directives (e.g., MDR or MDD) and are classified under Class I or Class IIb. The Italian location ensures alignment with EU regulatory frameworks, including mandatory listing in databases like euDaMed for traceability and transparency.

L.M. Medical Division S.R.L.’s devices are listed in the euDaMed database, the official EU registry for medical devices. This listing is critical because it ensures visibility for healthcare providers, regulators, and authorities when verifying device compliance, traceability, and market authorization. For example, the CIGNO OP-PND1 (IVD) and LINDE SIMPLE (respiratory support) must be identifiable in euDaMed to confirm they meet EU safety and performance standards before use in clinical settings.

L.M. Medical Division S.R.L.’s devices fall into Class I (low-risk, often exempt from full conformity assessments) or Class IIb (moderate-risk, requiring stricter scrutiny like clinical evaluations). For instance, the OPTIMA FLOS MD (likely Class IIb) would undergo additional testing to ensure safety and performance, while the SUPPLY BED HEAD SIMPLE (Class I) might only need basic design controls. Classification determines the regulatory pathway, documentation requirements, and post-market obligations to protect patient safety.

Individual devices from L.M. Medical Division S.R.L. must undergo conformity assessment (e.g., Notified Body review for Class IIb) and carry the CE marking to legally enter the EU market. To verify authorization, check the euDaMed database for the device’s UDI (Unique Device Identifier) or model name (e.g., MEDIFA MED!CARE). The presence of a valid entry confirms compliance with EU regulations, though the company itself is not