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
SkinCut	PU5.0	EUDAMED	Class IIa	Active
StimyUltra	AETR21150	EUDAMED	Class IIa	Active
PenBone Blu	PIP1530/70	EUDAMEDFDA UDI	Class IIa	Active
ThemyQ	TYQ1810	EUDAMED	Class IIa	Active
Palium Needle	MGK11420	EUDAMED	Class IIa	Active
Themy	TY2020	EUDAMEDFDA UDI	Class IIa	Active
MDCut P	MGP1620	EUDAMED	Class IIa	Active
StimyPlus	AETM21120	EUDAMED	Class IIa	Active
RepoMark	PR2005	EUDAMEDFDA UDI	Class IIa	Active
StimyUltra	AETR22035	EUDAMED	Class IIa	Active
Palium Needle	MGK11610	EUDAMEDFDA UDI	Class IIa	Active
VygoPlex ENS & Echo	AEQMV22080	EUDAMED	Class IIa	Active
AutoMarkX	PNAX2010	EUDAMEDFDA UDI	Class IIa	Active
Illy	PIL1535/100	EUDAMEDFDA UDI	Class IIa	Active
CytoCut	PB1807	EUDAMED	Class IIa	Active
PickUp	PJT0910	EUDAMED	Class IIa	Active
SemiCut	PD0PP1810	EUDAMEDFDA UDI	Class IIa	Active
Themy	TY1610	EUDAMEDFDA UDI	Class IIa	Active
Themy	TYC1816	EUDAMEDFDA UDI	Class IIa	Active
ToraSetValve	AV021510B	EUDAMED	Class IIa	Active
CytoCut	PB2110	EUDAMEDFDA UDI	Class IIa	Active
EasyCut	PC01915	EUDAMEDFDA UDI	Class IIa	Active
Mark	PN1812	EUDAMED	Class IIa	Active
PenBone	PI1610/75	EUDAMEDFDA UDI	Class IIa	Active
Wescott	PEW1815	EUDAMED	Class IIa	Active
PressTo	PS1310	EUDAMEDFDA UDI	Class IIa	Active
IllyE	PILE1410/75	EUDAMED	Class IIa	Active
MarkX	PNX1815	EUDAMED	Class IIa	Active
Themy	TY2010	EUDAMEDFDA UDI	Class IIa	Active
SemiCut	PD0PP1409	EUDAMED	Class IIa	Active
SemiCut	PD01820	EUDAMEDFDA UDI	Class IIa	Active
CytoCut	PB2212	EUDAMED	Class IIa	Active
Themy	TYC1825	EUDAMEDFDA UDI	Class IIa	Active
ThemySC	TYSC1612	EUDAMED	Class IIa	Active
VeressB	AVB1610	EUDAMED	Class IIa	Active
PenBone Blu	PIP1430/70	EUDAMEDFDA UDI	Class IIa	Active
CytoCut	PB2010	EUDAMEDFDA UDI	Class IIa	Active
ThemyQ	TYQ1825	EUDAMED	Class IIa	Active
SemiCut	PD01220	EUDAMED	Class IIa	Active
Palium Needle	MGC1416	EUDAMEDFDA UDI	Class IIa	Active
Themy	TY1811	EUDAMED	Class IIa	Active
EasyCut	PC01620	EUDAMED	Class IIa	Active
Themy	TY1410	EUDAMEDFDA UDI	Class IIa	Active
LightCut Plus	PD1610	EUDAMED	Class IIa	Active
CytoCut	PB2515	EUDAMED	Class IIa	Active
SemiCut	PD01415	EUDAMEDFDA UDI	Class IIa	Active
VygoPlex Echo	AEQMNVF22050	EUDAMED	Class IIa	Active
PenBone	PI1535/100	EUDAMEDFDA UDI	Class IIa	Active
Intro	PT15102	EUDAMED	Class IIa	Active
SemiCut	PD01611	EUDAMED	Class IIa	Active

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