Question 1

What types of medical devices does L.M. Medical Division S.R.L. primarily manufacture?

Accepted Answer

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.

Question 2

Where is L.M. Medical Division S.R.L. based, and how does this affect its regulatory compliance?

Accepted Answer

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.

Question 3

Which regulatory registries list L.M. Medical Division S.R.L.’s devices, and why is this important?

Accepted Answer

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.

Question 4

How are L.M. Medical Division S.R.L.’s devices classified under EU regulations, and what does this mean for their use?

Accepted Answer

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.

Question 5

Are L.M. Medical Division S.R.L.’s devices authorized for use in the EU, and how can I verify this?

Accepted Answer

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

Device	Model / Reference	Registries	Class	Status
Oki Vertical Htm	VERTICAL HTM	EUDAMED	Class IIb	Active
Optima Flos Lg	FLOS LG	EUDAMED	Class IIb	Active
Linde Panel	PANEL	EUDAMED	Class IIb	Active
Italia Roma Htm	ROMA HTM	EUDAMED	Class IIb	Active
Independant Flex S	FLEX S	EUDAMED	Class IIb	Active
Cigno Tt-Plus-Md	TT-PLUS-MD	EUDAMED	Class IIb	Active
Solido Motorized Horizontal	MOTORIZED HORIZONTAL	EUDAMED	Class IIb	Active
Life Fly	FLY	EUDAMED	Class IIb	Active
Italia Bergamo Column	BERGAMO COLUMN	EUDAMED	Class IIb	Active
Oki Basic Gas Sospesa	BASIC GAS SOSPESA	EUDAMED	Class IIb	Active
Oki Plus Es	PLUS ES	EUDAMED	Class IIb	Active
Italia Verona	VERONA	EUDAMED	Class IIb	Active
Oki Easy	EASY	EUDAMED	Class IIb	Active
Linde Stativ Isola Hotizontal	STATIV ISOLA HOTIZONTAL	EUDAMED	Class IIb	Active
Independant Care Basic Md	CARE BASIC MD	EUDAMED	Class IIb	Active
Italia Roma Lg	ROMA LG	EUDAMED	Class IIb	Active
Supply Bed Head Plus L	BED HEAD PLUS L	EUDAMED	Class IIb	Active
Independant Care Flat	CARE FLAT	EUDAMED	Class IIb	Active
Solido Wall	WALL	EUDAMED	Class IIb	Active
Optima Astra T	ASTRA T	EUDAMED	Class IIb	Active
Linde Allo Lg	ALLO LG	EUDAMED	Class IIb	Active
Oki Cielo Wall	CIELO WALL	EUDAMED	Class IIb	Active
Italia Trento	TRENTO	EUDAMED	Class IIb	Active
Independant Care Design	CARE DESIGN	EUDAMED	Class IIb	Active
Italia Torino Md	TORINO MD	EUDAMED	Class IIb	Active
Cigno Tt-Plus-Es	TT-PLUS-ES	EUDAMED	Class IIb	Active
Linde Allo Md	ALLO MD	EUDAMED	Class IIb	Active
Oki Flat	FLAT	EUDAMED	Class IIb	Active
Cigno Tt-Fantasy	TT-FANTASY	EUDAMED	Class IIb	Active
Oki Basic Gas Md	BASIC GAS MD	EUDAMED	Class IIb	Active
Oki Basic Gas Es	BASIC GAS ES	EUDAMED	Class IIb	Active
Cigno Tt-Vertical-Htm	TT-VERTICAL-HTM	EUDAMED	Class IIb	Active
Cigno Tt-Easy	TT-EASY	EUDAMED	Class IIb	Active
Independant Care Vertical Es	CARE VERTICAL ES	EUDAMED	Class IIb	Active
Optima Simplex Gas Lg	SIMPLEX GAS LG	EUDAMED	Class IIb	Active
Italia Genova	GENOVA	EUDAMED	Class IIb	Active
Cigno Tt-Plus-Lg	TT-PLUS-LG	EUDAMED	Class IIb	Active
Optima Evolutio Md	EVOLUTIO MD	EUDAMED	Class IIb	Active
Life V-Line-3	V-LINE-3	EUDAMED	Class IIb	Active
Italia Bergamo	BERGAMO	EUDAMED	Class IIb	Active
Life Kube	KUBE	EUDAMED	Class IIb	Active
Supply Pendo Station T	PENDO STATION T	EUDAMED	Class IIb	Active
Supply Bed Head Plus M	BED HEAD PLUS M	EUDAMED	Class IIb	Active
Life Smart	SMART	EUDAMED	Class IIb	Active
Optima Artem	ARTEM	EUDAMED	Class IIb	Active
Independant Care Infinit-I	INDEPENDANT CARE INFINIT-I	EUDAMED	Class IIb	Active
Independant Fix Bridge	FIX BRIDGE	EUDAMED	Class IIb	Active
I Control Plus	ICP-SCR43	EUDAMED	Class I	Active
Independant Care Basic Lg	CARE BASIC LG	EUDAMED	Class IIb	Active
Life Art	ART	EUDAMED	Class IIb	Active

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