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
Orion	OR1515	EUDAMEDFDA UDI	Class IIa	Active
Speedybell & Introduttore	SBTR1510EC	EUDAMEDFDA UDI	Class IIa	Active
Speedybell	SB1615C	EUDAMED	Class IIa	Active
Bpb Screwfix Rel Op/Mas	BPBSCREWFIXREL	EUDAMED	Class IIa	Active
Sternobell Explant	RNE1355	EUDAMEDFDA UDI	Class IIa	Active
Cystic Aspiration Needle	CYACH1830EC-20	EUDAMED	Class IIa	Active
Osteobell Explant	OBE1519CH6F	EUDAMED	Class IIa	Active
Vertebroneedle	KMVT1110000C-A	EUDAMED	Class IIa	Active
Screwfix	03.52.10.0746	EUDAMED	Class IIa	Active
Unlux System	ULSEC1310C	EUDAMEDFDA UDI	Class IIa	Active
Gamma	GM1720EC	EUDAMED	Class IIa	Active
Rti-V	RTI-VMG1510	EUDAMED	Class IIa	Active
VerteStable syringe with Luer-Lock Connection 2.5 ml (2 units / pouch)	458071	EUDAMED	Class I	Active
Kyphoset Balloon Catheter	KSB10J	EUDAMED	Class IIa	Active
Fully Remove	FU1517C	EUDAMED	Class IIa	Active
Orsi Gun	GUN1810ECISO	EUDAMED	Class IIa	Active
Osteobell Explant	OBE1310T	EUDAMED	Class IIa	Active
Orion Su Conetto	ORC1517	EUDAMED	Class IIa	Active
Iliac Marrow	IM1507	EUDAMEDFDA UDI	Class IIa	Active
Lipo-Stem	LPKIT-001	EUDAMED	Class IIa	Active
Chibell	CH2015EC-Y	EUDAMED	Class IIa	Active
Totally Remove	TOEC0811C	EUDAMED	Class IIa	Active
Ester	GUN2020EC10	EUDAMED	Class IIa	Active
Kyphokit Working Cannula And Bevel Tip	KK11-WB	EUDAMEDFDA UDI	Class IIa	Active
Renova Spine Kyphoplasty Tools Kit	RESFAST11-001	EUDAMEDFDA UDI	Class IIa	Active
Somacore Verify	900380-US	EUDAMEDFDA UDI	Class IIa	Active
Iliac Marrow	IM1612	EUDAMEDFDA UDI	Class IIa	Active
Vertebrosteel	KMFVT1110025C-A	EUDAMED	Class IIa	Active
Speedybell	SB1530EC	EUDAMEDFDA UDI	Class IIa	Active
Vertebral Biopsy Needle	RESBIO0812CP	EUDAMED	Class IIa	Active
Fully Remove	FU0715	EUDAMED	Class IIa	Active
Aspi Cut	181016	EUDAMED	Class IIa	Active
Biopsywest	WWM2207EC	EUDAMED	Class IIa	Active
Renova Spine Kyphoplasty Working Cannula And Bevel/Trocar Tip	RESWBTR1312C	EUDAMEDFDA UDI	Class IIa	Active
D-Tray	DTY1716CD	EUDAMED	Class IIa	Active
Speedybell Doppia Corsa	SBD1920EC	EUDAMEDFDA UDI	Class IIa	Active
Rti-Mis	RTI-MISG1512BP	EUDAMED	Class IIa	Active
Chibell	CH2511EC	EUDAMED	Class IIa	Active
Sternobell	RN1440	EUDAMEDFDA UDI	Class IIa	Active
Somacore Verify	900390	EUDAMED	Class IIa	Active
Osteoplasty Access System	TBP1112	EUDAMED	Class IIa	Active
Speedybell Doppia Corsa & Introduttore	SBDTR1818EC	EUDAMED	Class IIa	Active
Ester	GUN1610EC10	EUDAMED	Class IIa	Active
Biopsywest	WWM2107EC	EUDAMED	Class IIa	Active
Speedybell Doppia Corsa	SBD1425EC	EUDAMEDFDA UDI	Class IIa	Active
Core Biopsy Puncture Sheath V	170561-US	EUDAMED	Class IIa	Active
Biosoft	BSF2205C	EUDAMED	Class IIa	Active
Moon	MN2005EC	EUDAMED	Class IIa	Active
Iliac Marrow	IM1107	EUDAMEDFDA UDI	Class IIa	Active
Renova Spine Bone Filler	RESFIL1112C4B	EUDAMED	Class IIa	Active

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