Question 1

What types of medical devices does BiopsyBell Srl manufacture?

Accepted Answer

BiopsyBell Srl specializes in devices for minimally invasive orthopedic and hematological procedures. Their portfolio includes percutaneous diskectomy systems for spinal interventions, bone marrow biopsy tools like single-use needles and explantation kits, intraosseous infusion kits for emergency or chronic care, and specialized kits for kyphoplasty (e.g., balloon catheters and bone access channels). These devices are designed to streamline procedures like spinal disc removal, bone marrow sampling, and umbilical cord blood collection.

Question 2

Where is BiopsyBell Srl based, and how does that affect its devices?

Accepted Answer

BiopsyBell Srl is headquartered in Italy, which means its devices comply with EU Medical Device Regulations (MDR). The company’s products are classified under Class I, Class II, and Class IIa—categories that reflect varying levels of risk and regulatory scrutiny. Since Italy is part of the EU, these devices are listed in EUDAMED, the European database for medical devices, ensuring traceability and transparency for regulatory oversight.

Question 3

Which regulatory registries list BiopsyBell Srl’s devices?

Accepted Answer

BiopsyBell Srl’s devices are included in two key global registries: EUDAMED, the official EU database for medical device information, and the FDA’s UDI (Unique Device Identification) system in the United States. Listing in these databases helps healthcare providers verify device details, compliance status, and manufacturer information, ensuring safe and traceable use across markets.

Question 4

How are BiopsyBell Srl’s devices classified under EU regulations?

Accepted Answer

BiopsyBell Srl’s devices fall into Class I, Class II, and Class IIa under the EU Medical Device Regulations. The classification depends on factors like the device’s risk level, intended use, and potential impact on patient safety. For example, single-use bone marrow biopsy needles (low risk) are typically Class I, while more complex systems like kyphoplasty balloon catheters (moderate risk) may qualify as Class IIa. This classification determines the regulatory requirements for manufacturing, labeling, and post-market surveillance.

Question 5

Are BiopsyBell Srl’s devices used in both orthopedic and hematological procedures?

Accepted Answer

Yes, BiopsyBell Srl’s product range spans both orthopedic and hematological applications. Their diskectomy systems and kyphoplasty tools target spinal and bone interventions, while their bone marrow biopsy kits, explant needles, and umbilical cord blood collection devices serve hematological and regenerative medicine needs. This dual focus reflects the company’s expertise in minimally invasive techniques for both musculoskeletal and blood-related procedures.

Device	Model / Reference	Registries	Class	Status
Gamma	GM2510E	EUDAMED	Class IIa	Active
Gamma	GMRA2310EC	EUDAMED	Class IIa	Active
Speedybell	SB2020EC	EUDAMEDFDA UDI	Class IIa	Active
Introduttore	TR1815EC	EUDAMED	Class IIa	Active
Ester One Shot & Introduttore	GUNTR1415EC-OS	EUDAMED	Class IIa	Active
Iliac Marrow Explant	IME1310	EUDAMEDFDA UDI	Class IIa	Active
Optymarrow S	OMS1110-01	EUDAMED	Class IIa	Active
Speedybell Doppia Corsa & Introduttore	SBDTR2120EC	EUDAMEDFDA UDI	Class IIa	Active
K-Wire	116207	EUDAMED	Class IIa	Active
Introduttore	STR2110EC	EUDAMED	Class IIa	Active
Renova Spine Bone Filler	RESFIL1114C1DTB	EUDAMEDFDA UDI	Class IIa	Active
Introduttore	STR2005EC	EUDAMED	Class IIa	Active
Kyphokit Balloon Catheter	KBAL10MC	EUDAMED	Class IIa	Active
Somacore Verify S	900500-US	EUDAMEDFDA UDI	Class IIa	Active
Gamma	GM2025E	EUDAMED	Class IIa	Active
Diskom Introducer	DKRTR1716CD1FL10	EUDAMED	Class IIa	Active
Ester 13	GUN1825ECCH2-OS	EUDAMED	Class IIa	Active
Unlux System	ULSEC1115C	EUDAMEDFDA UDI	Class IIa	Active
Speedybell	SB2130EC	EUDAMEDFDA UDI	Class IIa	Active
Kyphokit Kirschner Guide	KK11-FGP	EUDAMEDFDA UDI	Class IIa	Active
Speedybell Doppia Corsa & Introduttore	SBDTR1707EC	EUDAMEDFDA UDI	Class IIa	Active
Renova Spine Balloon Catheter	RESB15MC	EUDAMED	Class IIa	Active
Cement Delivery Cannula	RW-SF092103	EUDAMED	Class IIa	Active
Biopsywest	WWM2015EC	EUDAMED	Class IIa	Active
Renova Spine Fast Access System	RES1112001VB	EUDAMED	Class IIa	Active
Fully Remove	FU1510C	EUDAMED	Class IIa	Active
Bone Access Needle	SZ364SU	EUDAMEDFDA UDI	Class IIa	Active
Osteobell “t”	OB0810TP	EUDAMED	Class IIa	Active
Diskom	DKR1716-01	EUDAMED	Class IIa	Active
Renova Spine Balloon Catheter	RESB15PM	EUDAMED	Class IIa	Active
Speedybell	SB1625EC	EUDAMEDFDA UDI	Class IIa	Active
Kyphokit Working Cannula And Bevel Tip	KK08-WB-AMS	EUDAMED	Class IIa	Active
Fully Remove	FUEC1515C	EUDAMED	Class IIa	Active
Vertebrosteel	KMFVT1115000C-A	EUDAMED	Class IIa	Active
Chibell	CH1915EC	EUDAMED	Class IIa	Active
Sternobell Explant	RNE1655	EUDAMEDFDA UDI	Class IIa	Active
Unlux System	ULS1115	EUDAMEDFDA UDI	Class IIa	Active
Speedybell Doppia Corsa	SBD1715EC	EUDAMEDFDA UDI	Class IIa	Active
Biosoft	BSF1905C	EUDAMED	Class IIa	Active
V-Strut Bone Filler	32600	EUDAMEDFDA UDI	Class IIa	Active
Speedybell	SB1730EC	EUDAMEDFDA UDI	Class IIa	Active
Iliac Marrow	IM1807	EUDAMEDFDA UDI	Class IIa	Active
Speedybell	SB1410EC	EUDAMEDFDA UDI	Class IIa	Active
Chibell	CH1815EC-Y	EUDAMED	Class IIa	Active
Fully Remove	FU1115	EUDAMED	Class IIa	Active
P-Inject	P-INJECT	EUDAMED	Class I	Active
Moon	MN2112EC	EUDAMED	Class IIa	Active
Stiletto Spingitore	KVE1115	EUDAMED	Class IIa	Active
Speedybell Doppia Corsa	SBD1415EC	EUDAMEDFDA UDI	Class IIa	Active
Speedybell	SB1515EC	EUDAMEDFDA UDI	Class IIa	Active

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