BEUDAMED
    FDA Registration Active 🇮🇹 Italy

    BIOPSYBELL S.R.L.

    Reg #: 9617616 · FEI: 3003272754 · Expires 2026
    View on FDA
    Products
    16
    Proprietary Names
    109
    Establishment Types
    3
    Classifications
    16

    Registration Details

    Registration Name
    BIOPSYBELL S.R.L.
    Registration Number
    9617616
    FEI Number
    3003272754
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    Via A.Manuzio n.24
    City
    MIRANDOLA Modena
    Country
    IT

    Regulatory Submissions

    510(k) Number
    K180315

    Owner / Operator

    Firm Name
    BIOPSYBELL S.R.L.
    Operator Number
    9050785
    Address
    Via A. Manuzio N.24
    City
    MIRANDOLA (MO)
    State
    Modena
    Postal Code
    41037
    Country
    IT
    Correspondent
    NICOLA - SCAGLIARINI

    Products

    Device Name Product Code
    Injector, Vertebroplasty (Does Not Contain Cement) OAR
    Arthroscope HRX
    Spinal Channeling Instrument, Vertebroplasty OCJ
    Mixer, Cement, For Clinical Use JDZ
    Device, Percutaneous, Biopsy MJG
    Instrument, Biopsy KNW
    Biopsy Needle FCG
    Cement, Bone, Vertebroplasty NDN
    Thoracolumbosacral Pedicle Screw System NKB
    Bone Cement, Posterior Screw Augmentation PML
    Bone Cement LOD
    Guide, Needle, Surgical GDF
    Needle, Aspiration And Injection, Disposable GAA
    Orthopedic Manual Surgical Instrument LXH
    Condenser, Heat And Moisture (Artificial Nose) BYD
    Brace, Drill HXY

    Proprietary Names

    KYPHOTRAY BONE FILLER VERTEBROPLASTY SYRINGES (2-3-5cc) VERTEBROPLASTY EXTENSION LINES EASYNJECT RENOVA SPINE BONE FILLER SCREWFIX Easynject “S” KYPHOKIT BONE FILLER CIFOPACK BONE FILLER V-STRUT BONE FILLER CEMENT DELIVERY CANNULA KYPHOSET BONE FILLER DISKOM KYPHOTRAY WORKING CANNULA AND DIAMOND TIP KYPHOSET WORKING CANNULA AND TROCAR TIP KYPHOSET WORKING CANNULA AND EXPANDER KYPHOTRAY WORKING CANNULA AND BEVEL/TROCAR TIP RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND DIAMOND TIP RENOVA SPINE FAST ACCESS SYSTEM RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND TROCAR TIP RENOVA SPINE CLASSIC ACCESS SYSTEM RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL TIP RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND EXPANDER RENOVA SPINE KYPHOPLASTY BONE ACCESS NEEDLE RENOVA SPINE KYPHOPLASTY WORKING CANNULA AND BEVEL/TROCAR TIP RENOVA SPINE KYPHOPLASTY TOOL KIT VERTEBROPLASTIC CIFOPACK WORKING CANNULA AND TROCAR TIP VERTEBROSTEEL CIFOPACK CLASSIC ACCESS SYSTEM KYPHOKIT CLASSIC ACCESS SYSTEM KYPHOKIT FAST ACCESS SYSTEM CIFOPACK FAST ACCESS SYSTEM KYPHOKIT BONE ACCESS NEEDLE KYPHOKIT WORKING CANNULA AND TROCAR TIP KYPHOKIT WORKING CANNULA AND EXPANDER CIFOPACK WORKING CANNULA AND BEVEL TIP KYPHOKIT WORKING CANNULA AND BEVEL TIP CIFOPACK BONE ACCESS NEEDLE CIFOPACK WORKING CANNULA AND DIAMOND TIP KYPHOKIT WORKING CANNULA AND BEVEL/TROCAR TIP CIFOPACK WORKING CANNULA AND BEVEL/TROCAR TIP KYPHOKIT WORKING CANNULA AND DIAMOND TIP KYPHOTRAY FAST ACCESS SYSTEM KYPHOSET WORKING CANNULA AND BEVEL/TROCAR TIP KYPHOTRAY WORKING CANNULA AND BEVEL TIP KYPHOSET WORKING CANNULA AND BEVEL TIP KYPHOSET FAST ACCESS SYSTEM KYPHOTRAY CLASSIC ACCESS SYSTEM KYPHOTRAY WORKING CANNULA AND TROCAR TIP KYPHOTRAY BONE ACCESS NEEDLE KYPHOSET BONE ACCESS NEEDLE CIFOPACK WORKING CANNULA AND EXPANDER KYPHOSET WORKING CANNULA AND DIAMOND TIP KYPHOTRAY WORKING CANNULA AND EXPANDER KYPHOSET CLASSIC ACCESS SYSTEM CEMIX CEMENT MIXING SYSTEM INTRODUCER CORE BIOPSY PUNCTURE SHEATH V ILIAC-MARROW EXPLANT: Needle for bone-marrow explant SPEEDYBELL DOPPIA CORSA & INTRODUTTORE: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY UNLUX SYSTEM: Needle for bone-marrow biopsy TOTALLY REMOVE: Needle for bone-marrow biopsy STERNOBELL: Needle for bone-marrow biopsy SPEEDYBELL & INTRODUTTORE: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY ESTER & INTRODUTTORE: AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY MANUAL NEEDLES FOR BONE MARROW BIOPSY OBSTERN EXPLANT: Needle for bone-marrow explant OBSTERN: Needle for bone-marrow biopsy STERNOBELL EXPLANT: Needle for bone-marrow explant ORlON EXPLANT: Needle for bone-marrow explant OSTEOBELL 'T': Needle for bone-marrow biopsy SPEEDYBELL DOPPIA CORSA: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY AUTOMATIC GUILLOTINE NEEDLE ORlON: Needle for bone-marrow biopsy ESTER: AUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY SPEEDYBELL: SEMIAUTOMATIC GUILLOTINE NEEDLE FOR SOFT-TISSUE BIOPSY ILIAC-MARROW: Needle for bone-marrow biopsy SEMIAUTOMATIC GUILLOTINE NEEDLES OSTEOBELL EXPLANT: Needle for bone-marrow explant ESTER ONE SHOT KYPHOPLASTY BALLOON CATHETER BonOs Inject KYPHOTRAY KIRSCHNER GUIDE RENOVA SPINE KYPHOPLASTY KIRSCHNER GUIDE K-WIRE CIFOPACK KIRSCHNER GUIDE KYPHOKIT KIRSCHNER GUIDE KYPHOSET KIRSCHNER GUIDE ORTHOPLASTY Renova Spine Balloon Catheter BONE ACCESS NEEDLE OSTEOPEARL BONE FILLER OSTEOPEARL ACCESS CANNULA & BEVELED TIP TROCAR OSTEOPEARL ACCESS CANNULA & DIAMOND TIP TROCAR OSTEOPEARL DRILL EASY BREATH HUMITRACH HME RENOVA SPINE KYPHOPLASTY DRILL KYPHOKIT DRILL CIFOPACK DRILL KYPHOTRAY DRILL KYPHOSET DRILL BONE MARROW MSC ASPIRATION KIT- MARROW-SET BONE MARROW MSC ASPIRATION KIT- MARROW-STEM BONE MARROW MSC ASPIRATION KIT- MARROW-PACK BONE MARROW MSC ASPIRATION KIT- MARROW-TRAY BONE MARROW MSC ASPIRATION KIT- MARROW- KIT

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Export Device to the United States But Perform No Other Operation on Device