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
SemiCut	PD0PP2020	EUDAMEDFDA UDI	Class IIa	Active
CytoCut	PB2320	EUDAMED	Class IIa	Active
VeressB	AVB1412	EUDAMED	Class IIa	Active
EasyCut	PC02010	EUDAMED	Class IIa	Active
MDCut P	MGP1810	EUDAMED	Class IIa	Active
ToraSet	AV011410B	EUDAMED	Class IIa	Active
VygoPlex ENS & Echo	AEYMVF21120	EUDAMED	Class IIa	Active
EpaSet	PA2009	EUDAMED	Class IIa	Active
PenBone Blu	PIP1810/50	EUDAMEDFDA UDI	Class IIa	Active
Illy	PIL1610/75	EUDAMEDFDA UDI	Class IIa	Active
Intro	PT15072	EUDAMED	Class IIa	Active
CytoCut	PB2215	EUDAMEDFDA UDI	Class IIa	Active
StimyPlus	AEQM22090	EUDAMED	Class IIa	Active
SemiCut	PD0PP1407	EUDAMEDFDA UDI	Class IIa	Active
Wescott	PEW1820	EUDAMED	Class IIa	Active
StimyUltra	AEQR22050	EUDAMED	Class IIa	Active
CytoCut	PB2107	EUDAMED	Class IIa	Active
CytoCut	PB1710	EUDAMED	Class IIa	Active
VygoPlex ENS & Echo	AEYMV21100	EUDAMED	Class IIa	Active
Intro	PT17140	EUDAMEDFDA UDI	Class IIa	Active
SemiCut	PD01630	EUDAMED	Class IIa	Active
EasyCut	PC01710	EUDAMED	Class IIa	Active
StimyUltra	AETR21090	EUDAMED	Class IIa	Active
StimyUltra	AETR23035	EUDAMED	Class IIa	Active
MDCut E	VE1620	EUDAMED	Class IIa	Active
SemiCut	PD0PP1416	EUDAMEDFDA UDI	Class IIa	Active
Intro	PT13110	EUDAMED	Class IIa	Active
Amnio	PBU2112	EUDAMED	Class IIa	Active
StimyPlus	AEYH21120	EUDAMED	Class IIa	Active
Illy	PIL1420/85	EUDAMED	Class IIa	Active
Amnio	PBU2020	EUDAMED	Class IIa	Active
Intro	PT17152	EUDAMED	Class IIa	Active
EasyLock	PC2015	EUDAMED	Class IIa	Active
CytoCut	PB1910	EUDAMED	Class IIa	Active
SemiCut	PD01816	EUDAMEDFDA UDI	Class IIa	Active
VygoPlex ENS & Echo	AEYMV22050	EUDAMED	Class IIa	Active
ThemyQ	TYQ1620	EUDAMED	Class IIa	Active
MDCut E	VE1815	EUDAMED	Class IIa	Active
ThemyQ	TYQ1616	EUDAMED	Class IIa	Active
SemiCut	PD0PP2010	EUDAMEDFDA UDI	Class IIa	Active
Themy	TY1620	EUDAMEDFDA UDI	Class IIa	Active
Intro	PT15075	EUDAMED	Class IIa	Active
Amnio	PBU2215	EUDAMED	Class IIa	Active
CytoCut	PB14070	EUDAMED	Class IIa	Active
SemiCut	PD01620	EUDAMEDFDA UDI	Class IIa	Active
EasyCut	PC01910	EUDAMED	Class IIa	Active
ToraSetValve	AV021810B	EUDAMED	Class IIa	Active
MarkZ	PNZ2015	EUDAMED	Class IIa	Active
MDCut E	VE1415	EUDAMED	Class IIa	Active
Themy	TYC1610	EUDAMEDFDA UDI	Class IIa	Active

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