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
Cifopack Bone Filler	KPA11-FIL3	EUDAMED	Class IIa	Active
Somacore Verify S	900514	EUDAMED	Class IIa	Active
Vertebroplastic	KRVT1113225CBP-A	EUDAMED	Class IIa	Active
Cifopack Fast Access System	KPA11-001V	EUDAMEDFDA UDI	Class IIa	Active
Gamma	GM1715EC	EUDAMED	Class IIa	Active
Chibell	CH2220EC	EUDAMED	Class IIa	Active
Speedybell	SB1407EC	EUDAMEDFDA UDI	Class IIa	Active
Moon	MN2115LEC	EUDAMED	Class IIa	Active
Chibell	CH2505EC	EUDAMED	Class IIa	Active
Introduttore	STR1615EC	EUDAMED	Class IIa	Active
Gamma	GM2212ECP15	EUDAMED	Class IIa	Active
Vertebroplastic	KRVT1010232C-A	EUDAMED	Class IIa	Active
Renova Spine Classic Access System	RES0812001L	EUDAMEDFDA UDI	Class IIa	Active
Core Biopsy Puncture Sheath V	170553-US	EUDAMED	Class IIa	Active
Fully Remove	KK11-FU-AMS	EUDAMED	Class IIa	Active
Speedybell Doppia Corsa	SBD1625EC	EUDAMEDFDA UDI	Class IIa	Active
Introduttore	TR1510EC	EUDAMED	Class IIa	Active
Vert-Steel	VKM-1115	EUDAMED	Class IIa	Active
Rti-K	RTI-KDC6	EUDAMED	Class IIa	Active
Kyphokit Balloon Catheter	KBAL15	EUDAMED	Class IIa	Active
Biopsy Handy	900120	EUDAMED	Class IIa	Active
Bone Access Needle	BAN1110CDT	EUDAMEDFDA UDI	Class IIa	Active
Osteobell “t”	OB1115T	EUDAMEDFDA UDI	Class IIa	Active
Aspynfinity	ASPY05	EUDAMED	Class I	Active
Biosoft	BSF1620C	EUDAMED	Class IIa	Active
Ester One Shot	GUN1615EC-OS	EUDAMEDFDA UDI	Class IIa	Active
Orion	OR1610	EUDAMEDFDA UDI	Class IIa	Active
Cifopack Bone Filler	KPA11-FILCH3	EUDAMED	Class IIa	Active
Chibell	CH2120EC-Y	EUDAMED	Class IIa	Active
Kirschner Wire ø 1.4 mm L 400 mm	03.75.10.0205	EUDAMEDFDA UDI	Class IIa	Active
Sternobell Explant	RNE1325	EUDAMEDFDA UDI	Class IIa	Active
Speedybell & Introduttore	SBTR1720EC	EUDAMEDFDA UDI	Class IIa	Active
Orion	OR1615	EUDAMEDFDA UDI	Class IIa	Active
Unlux System	ULSEC0810C	EUDAMEDFDA UDI	Class IIa	Active
Beauty-Stem Duo	BETKIT-005A	EUDAMED	Class IIa	Active
Somacore Verify	900406-US	EUDAMED	Class IIa	Active
Speedybell Doppia Corsa & Introduttore	SBDTR1807EC	EUDAMEDFDA UDI	Class IIa	Active
Introduttore	STR1807EC	EUDAMED	Class IIa	Active
Osteobell Explant	OBE1513T	EUDAMEDFDA UDI	Class IIa	Active
Chibell Con Siringa	CH2120ECSI2	EUDAMED	Class IIa	Active
Biosoft	BSF1820C	EUDAMED	Class IIa	Active
Screwfix	SF092713C1	EUDAMED	Class IIa	Active
Sternobell Explant	RNE1575	EUDAMED	Class IIa	Active
Gamma	GM1909EC	EUDAMED	Class IIa	Active
Unlux System	ULS0810	EUDAMEDFDA UDI	Class IIa	Active
Osteobell Explant	OBE1113T	EUDAMEDFDA UDI	Class IIa	Active
Gamma	GM2112EC	EUDAMED	Class IIa	Active
Sternobell Explant	RNE1825	EUDAMEDFDA UDI	Class IIa	Active
Fully Remove	FU1317C	EUDAMED	Class IIa	Active
Kyphokit Vertebral Biopsy Needle	KK11-FU1520	EUDAMED	Class IIa	Active

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