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
Themy	TYC1610	EUDAMEDFDA UDI	Class IIa	Active
IllyE	PILE1510/75	EUDAMED	Class IIa	Active
StimyEcho	AEQMN22080	EUDAMED	Class IIa	Active
MarkX	PNX2015	EUDAMEDFDA UDI	Class IIa	Active
ThemyQ	TYQ1416	EUDAMED	Class IIa	Active
MDCut E	VE1825	EUDAMED	Class IIa	Active
EasyLock	PC2115	EUDAMED	Class IIa	Active
Intro	PT13080	EUDAMED	Class IIa	Active
ToraSet	AV011510B	EUDAMED	Class IIa	Active
StimyUltra	AETR22100	EUDAMED	Class IIa	Active
Amnio	PBU2220	EUDAMED	Class IIa	Active
Palium Needle	MGK11613	EUDAMED	Class IIa	Active
EasyCut	PC01920	EUDAMED	Class IIa	Active
Intro	PT13046	EUDAMED	Class IIa	Active
SemiCut	PD01807	EUDAMED	Class IIa	Active
CytoCut	PB2020	EUDAMEDFDA UDI	Class IIa	Active
LightCut Plus	PD1410	EUDAMED	Class IIa	Active
Intro	PT11044	EUDAMED	Class IIa	Active
EpaSet	PA1509	EUDAMED	Class IIa	Active
CytoCut	PB2120	EUDAMEDFDA UDI	Class IIa	Active
SemiCut	PD0PP1615	EUDAMEDFDA UDI	Class IIa	Active
MDCut P	MGP1410	EUDAMEDFDA UDI	Class IIa	Active
ThemyQ	TYQ1625	EUDAMED	Class IIa	Active
CytoCut	PB2225	EUDAMEDFDA UDI	Class IIa	Active
StimyPlus	AETM22050	EUDAMED	Class IIa	Active
ParaSet	AV01K5	EUDAMED	Class IIa	Active
PressTo	PS1110	EUDAMEDFDA UDI	Class IIa	Active
ThemyQ	TYQ1820	EUDAMED	Class IIa	Active
CytoCut	PB2315	EUDAMED	Class IIa	Active
EasyCut	PC02015	EUDAMED	Class IIa	Active
Harvest	PJE1310	EUDAMED	Class IIa	Active
PenBone	PI1825/90	EUDAMED	Class IIa	Active
Palium Needle	MGC1413	EUDAMEDFDA UDI	Class IIa	Active
PenBoneE	PIE1435/100	EUDAMED	Class IIa	Active
MDCut E	VE1616	EUDAMED	Class IIa	Active
VygoPlex Echo	AEYMNVF22080	EUDAMED	Class IIa	Active
Illy	PIL1435/100	EUDAMEDFDA UDI	Class IIa	Active
GalaKitDuo	PZYC3015	EUDAMED	Class IIa	Active
Illy	PIL1520/85	EUDAMED	Class IIa	Active
PenBone Blu	PIP1455/95	EUDAMED	Class IIa	Active
MarkX	PNX1805	EUDAMEDFDA UDI	Class IIa	Active
CytoCut	PB2209	EUDAMED	Class IIa	Active
CytoCut	PB1707	EUDAMED	Class IIa	Active
Palium Needle	MGC1410	EUDAMEDFDA UDI	Class IIa	Active
SemiCut	PD01412	EUDAMED	Class IIa	Active
Intro	PT13040	EUDAMED	Class IIa	Active
PenBone Blu	PIP1510/50	EUDAMEDFDA UDI	Class IIa	Active
ThemyQ	TYQ1420	EUDAMED	Class IIa	Active
CytoCut	PB2012	EUDAMED	Class IIa	Active
RepoMark	PR2010	EUDAMEDFDA UDI	Class IIa	Active

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