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
Harvest	PJE1306	EUDAMED	Class IIa	Active
Intro	PT17073	EUDAMED	Class IIa	Active
VeressB	AVB1405	EUDAMED	Class IIa	Active
Illy	PIL1810/75	EUDAMEDFDA UDI	Class IIa	Active
MDCut P	MGP1612	EUDAMEDFDA UDI	Class IIa	Active
RF BLUNT Straight Cannula	RF0M22050R10A	EUDAMED	Class IIa	Active
VeressC	AVC1612	EUDAMED	Class IIa	Active
PenBone Blu	PIP1410/50	EUDAMEDFDA UDI	Class IIa	Active
StimyPlus	AETM21150	EUDAMED	Class IIa	Active
IllyE	PILE1520/85	EUDAMED	Class IIa	Active
SkinCut	PU8.0	EUDAMED	Class IIa	Active
AutoMark	PNA1810	EUDAMED	Class IIa	Active
StimyUltra	AETR22050	EUDAMED	Class IIa	Active
OsteoJ	PJ1110	EUDAMEDFDA UDI	Class IIa	Active
ParaSet	AV01K8	EUDAMED	Class IIa	Active
Illy	PIL1410/75	EUDAMEDFDA UDI	Class IIa	Active
Intro	PT16100	EUDAMED	Class IIa	Active
SemiCut Semi-automatic Biopsy Needle, Themy Automatic Disposable Biopsy Device, Palium Automatic Reusable Biopsy Device, EasyCut Semi-automatic Biopsy Needle, MDL Biopsy and Coaxial Introducer Needles	K160316	FDA 510(k)	Class II	Active
Illy	PIL1620/85	EUDAMED	Class IIa	Active
EasyCut	PC01615	EUDAMED	Class IIa	Active
PenBone	PI1810/75	EUDAMEDFDA UDI	Class IIa	Active
MDCut P	MGP1825	EUDAMEDFDA UDI	Class IIa	Active
CytoCut	PB1815	EUDAMEDFDA UDI	Class IIa	Active
MDCut P	MGP1820	EUDAMEDFDA UDI	Class IIa	Active
RepoMarkD	PRD2007	EUDAMED	Class IIa	Active
Intro	PT15112	EUDAMED	Class IIa	Active
CytoCut	PB1820	EUDAMEDFDA UDI	Class IIa	Active
CytoCut	PB2210	EUDAMEDFDA UDI	Class IIa	Active
ThemyQC	TYQC1410	EUDAMED	Class IIa	Active
Themy	TY1810	EUDAMEDFDA UDI	Class IIa	Active
PenBone	PI1425/90	EUDAMED	Class IIa	Active
CytoCut	PB1825	EUDAMEDFDA UDI	Class IIa	Active
SemiCut	PD0PP1812	EUDAMED	Class IIa	Active
LightCut Plus	PD1615	EUDAMED	Class IIa	Active
PickUpD	PJTD0815	EUDAMED	Class IIa	Active
Mark	PN1810	EUDAMED	Class IIa	Active
Amnio	PBU2022	EUDAMED	Class IIa	Active
Themy	TY1816	EUDAMEDFDA UDI	Class IIa	Active
EasyCut	PC02020	EUDAMEDFDA UDI	Class IIa	Active
Palium Needle	MGK11615	EUDAMEDFDA UDI	Class IIa	Active
PenBoneE	PIE1635/100	EUDAMED	Class IIa	Active
MarkZ	PNZ1815	EUDAMED	Class IIa	Active
OsteoJ	PJH0810	EUDAMED	Class IIa	Active
CytoCut	PB2310	EUDAMED	Class IIa	Active
Themy	TYC1410	EUDAMEDFDA UDI	Class IIa	Active
Palium Needle	MGK11825	EUDAMEDFDA UDI	Class IIa	Active
Themy	TYC1616	EUDAMED	Class IIa	Active
Illy	PIL1635/100	EUDAMEDFDA UDI	Class IIa	Active
EasyLock	PC1815	EUDAMEDFDA UDI	Class IIa	Active
ThemyQ	TYQ1816	EUDAMED	Class IIa	Active

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