Question 1

What types of medical devices does M.D.L. S.R.L. manufacture?

Accepted Answer

M.D.L. S.R.L. manufactures end-cut biopsy gun handpieces and needles, bone marrow biopsy needles, body aspiration needles, orthopaedic coaxial injection applicators, radiological image markers, soft-tissue biopsy procedure kits, and percutaneous automatic diskectomy systems.

The company's devices are classified as Class A, Class I, Class II, and Class IIa, and are listed in Eudamed, FDA 510(k), and FDA UDI registries. M.D.L. S.R.L. is based in Italy.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Question 2

Where is M.D.L. S.R.L. based?

Accepted Answer

M.D.L. S.R.L. is based in Italy, as indicated by the COUNTRY field set to IT and confirmed in the SUMMARY section of the device data.

Question 3

In which regulatory registries are M.D.L. S.R.L.'s devices listed?

Accepted Answer

M.D.L. S.R.L.'s devices are listed in Eudamed, FDA 510(k), and FDA UDI registries, as stated in the LISTED IN field and reiterated in the SUMMARY section of the provided data.

Question 4

How are M.D.L. S.R.L.'s devices classified under regulatory systems?

Accepted Answer

M.D.L. S.R.L.'s devices are classified as Class A, Class I, Class II, and Class IIa, based on the DEVICE CLASSES field and confirmed in the SUMMARY, which explicitly lists these classification levels without implying company-wide approval.

Device	Model / Reference	Registries	Class	Status
FastCutE	VE1410	FDA UDI	Class I	Active
SemiCut Coax.	PD0PP1615	FDA UDI	Class II	Active
Intro	PT17044	FDA UDI	Class I	Active
CytoCut	PB1815	FDA UDI	Class I	Active
Illy	PIL1810/75	FDA UDI	Class I	Active
Themy	TY1820	FDA UDI	Class II	Active
SemiCut	PD01416	FDA UDI	Class II	Active
Intro	PT17110	FDA UDI	Class I	Unknown
RepoMark	PR2007	FDA UDI	Class I	Active
Lipo	LP25180111	FDA UDI	Class I	Active
JamBlu	PJK21110	FDA UDI	Class I	Active
HandCut	PM1610	FDA UDI	Class I	Unknown
Themy	TY1420	FDA UDI	Class II	Active
Illy	PIL1410/75	FDA UDI	Class I	Active
SemiCut	PD01616	FDA UDI	Class II	Active
Themy	TY1610	FDA UDI	Class II	Active
Intro	PT15052	FDA UDI	Class I	Active
Illy	PIL1610/75	FDA UDI	Class I	Active
HandCut	PM1815	FDA UDI	Class I	Active
EasyCut	PC01610	FDA UDI	Class II	Active
OsteoJ	PJ1115	FDA UDI	Class I	Active
HandCut	PM1415	FDA UDI	Class I	Active
HandCut	PM14114	FDA UDI	Class I	Unknown
HandCut	PM14074	FDA UDI	Class I	Unknown
Themy	TY1416	FDA UDI	Class II	Active
Palium Needle	MGK11616	FDA UDI	Class I	Active
HandCut	PM18114	FDA UDI	Class I	Active
Illy	PIL1535/100	FDA UDI	Class I	Active
RepoMark	PR2015	FDA UDI	Class I	Unknown
SemiCut	PD0PP1420	FDA UDI	Class II	Unknown
OsteoJ	PJ0810	FDA UDI	Class I	Active
Intro	PT17110	FDA UDI	Class I	Active
Themy	TYC1410	FDA UDI	Class II	Active
Themy	TYC2020	FDA UDI	Class II	Unknown
RepoMark	PR2005	FDA UDI	Class I	Active
Themy	TY1206	FDA UDI	Class II	Active
Intro	PT13044	FDA UDI	Class I	Active
Themy	TY1206	FDA UDI	Class II	Unknown
SemiCut	PD01615	FDA UDI	Class II	Active
EasyLock	PC1610	FDA UDI	Class I	Active
Illy	PIL1635/100	FDA UDI	Class I	Active
Harvest	PJE1110	FDA UDI	Class I	Active
CytoCut	PB1810	FDA UDI	Class I	Active
SemiCut	PD01410	FDA UDI	Class II	Active
Palium Needle	MGK11820	FDA UDI	Class I	Active
Themy	TY1209	FDA UDI	Class II	Active
SemiCut Coax.	PD0PP1825	FDA UDI	Class II	Active
HandCut	PM18075	FDA UDI	Class I	Active
Mark	PN2015	FDA UDI	Class I	Active
HandCut	PM16075	FDA UDI	Class I	Active

M.D.L. S.R.L.

What M.D.L. S.R.L. makes

Frequently asked questions

Information

Catalogue (594)

Related Companies

Authorised Representatives

Importers

Notified Bodies

Authorities