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
Independant Fix Ceiling	FIX CEILING	EUDAMED	Class IIb	Active
Oki Vertical Lg	VERTICAL LG	EUDAMED	Class IIb	Active
Life C-Sky	C-SKY	EUDAMED	Class IIb	Active
Life Mb-Sky	MB-SKY	EUDAMED	Class IIb	Active
Life Motion-O	MOTION-O	EUDAMED	Class IIb	Active
Life S-Line-3	S-LINE-3	EUDAMED	Class IIb	Active
Linde Color	COLOR	EUDAMED	Class IIb	Active
Independant Care Vertical Htm	CARE VERTICAL HTM	EUDAMED	Class IIb	Active
Life D-Line-S	D-LINE-S	EUDAMED	Class IIb	Active
Italia Pisa	PISA	EUDAMED	Class IIb	Active
Cigno Tt-Basic-Md	TT-BASIC-MD	EUDAMED	Class IIb	Active
Italia Torino Lg	TORINO LG	EUDAMED	Class IIb	Active
Atlas	COLUMN	EUDAMED	Class IIb	Active
Optima Insula Moto V (ref. Vertical)	INSULA MOTO V (REF. VERTICAL)	EUDAMED	Class IIb	Active
Linde Allo Es	ALLO ES	EUDAMED	Class IIb	Active
Life V-Line-2	V-LINE-2	EUDAMED	Class IIb	Active
Oki Basic Gas Lg	BASIC GAS LG	EUDAMED	Class IIb	Active
Italia Milano Gas Md	MILANO GAS MD	EUDAMED	Class IIb	Active
Independant Care Horizontal Lg	CARE HORIZONTAL LG	EUDAMED	Class IIb	Active
Optima Evolutio Lg	EVOLUTIO LG	EUDAMED	Class IIb	Active
Supply Bed Head Basic S	BED HEAD BASIC S	EUDAMED	Class IIb	Active
Supply Pendo Motion Mv	PENDO MOTION MV	EUDAMED	Class IIb	Active
Cigno Op-Square	OP-SQUARE	EUDAMED	Class IIb	Active
Optima Venus	VENUS	EUDAMED	Class IIb	Active
Optima Astra C	ASTRA C	EUDAMED	Class IIb	Active
Optima Simplex Gas Es	SIMPLEX GAS ES	EUDAMED	Class IIb	Active
Solido Motorized Vertical	MOTORIZED VERTICAL	EUDAMED	Class IIb	Active
Life S-Line-Gs	S-LINE-GS	EUDAMED	Class IIb	Active
Life S-Line-2	S-LINE-2	EUDAMED	Class IIb	Active
Alvo Callisto	CALLISTO MOTORIZED	EUDAMED	Class IIb	Active
Linde Stativ	STATIV	EUDAMED	Class IIb	Active
Alvo Luna	MEDIA BRIDGE	EUDAMED	Class IIb	Active
Italia Brescia	BRESCIA	EUDAMED	Class IIb	Active
Italia Milano Gas Sospesa	MILANO GAS SOSPESA	EUDAMED	Class IIb	Active
Linde Dizajn	DIZAJN	EUDAMED	Class IIb	Active
Linde Alap Pendant	ALAP PENDANT	EUDAMED	Class IIb	Active
Cigno Tt-Flat	TT-FLAT	EUDAMED	Class IIb	Active
Optima Astra	ASTRA	EUDAMED	Class IIb	Active
Oki Plus Lg	PLUS LG	EUDAMED	Class IIb	Active
Oki Cielo Teatro	CIELO TEATRO	EUDAMED	Class IIb	Active
Linde Alap Lg	ALAP LG	EUDAMED	Class IIb	Active
Linde Allo Htm	ALLO HTM	EUDAMED	Class IIb	Active
Cigno Ic-Wall	IC-WALL	EUDAMED	Class IIb	Active
Oki Quadro	QUADRO	EUDAMED	Class IIb	Active
Supply Bed Head Versatile	BED HEAD VERSATILE	EUDAMED	Class IIb	Active
Independant Care Vertical Lg	CARE VERTICAL LG	EUDAMED	Class IIb	Active
Optima Fabula	FABULA	EUDAMED	Class IIb	Active
Medifa Med!care	MED!CARE V-DESIGN	EUDAMED	Class IIb	Active
Atlas	PLL	EUDAMED	Class IIb	Active
Oki Vertical Md	VERTICAL MD	EUDAMED	Class IIb	Active

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

About

What L.M. MEDICAL DIVISION S.R.L. makes

Frequently asked questions

Information

Catalogue (209)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities