Biopsybell S.R.L.

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Web: http://www.biopsybell.it
E-Mail:
Address: Via Lea Cazzvoli 14/16, S. Giacomo Roncole, Mirandola (mo), IT-MO 41037, Italy
Phone: +39-(0535)-27850 | Fax: +39-(0535)-33526 | Map/Directions >>

Profile: Biopsybell S.R.L. is a designer and manufacturer of health-care products. We are an ISO 13485:2003 certified company. Our DHRST synovial biopsy can be used for the removal of synovial tissue of the knee joint. This type of needle allows the diagnosis & identification of particular pathology in the knee joint such as synovitis, which is painful inflammation associated with particular infections. Our Fully Remove needle is a needle designed for bone marrow biopsy. Our Biosoft is a disposable suction machine used in histological biopsies.

The company is ISO 13485:2003 certified.

FDA Registration Number: 9617616
US Agent: Willer Ghelfi
Phone: +1-(973)-519-0431 E-Mail:

5 Products/Services (Click for related suppliers)

• Biopsy Instruments (FDA Code: KNW / 876.1075)

A gastroenterology-urology biopsy instrument is a device used to remove, by cutting or aspiration, a specimen of tissue for microscopic examination. This generic type of device includes the biopsy punch, gastrointestinal mechanical biopsy instrument, suction biopsy instrument, gastro-urology biopsy needle and needle set, and nonelectric biopsy forceps. This section does not apply to biopsy instruments that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

• Biopsy Instruments (FDA Code: KNW / 876.1075)

• Biopsy Needle Kit (FDA Code: FCG / 876.1075)

• Disposable Aspiration and Injection Needle (FDA Code: GAA / 878.4800)

A manual surgical instrument for general use is a nonpowered, hand-held, or hand-manipulated device, either reusable or disposable, intended to be used in various general surgical procedures. The device includes the applicator, clip applier, biopsy brush, manual dermabrasion brush, scrub brush, cannula, ligature carrier, chisel, clamp, contractor, curette, cutter, dissector, elevator, skin graft expander, file, forceps, gouge, instrument guide, needle guide, hammer, hemostat, amputation hook, ligature passing and knot-tying instrument, knife, blood lancet, mallet, disposable or reusable aspiration and injection needle, disposable or reusable suturing needle, osteotome, pliers, rasp, retainer, retractor, saw, scalpel blade, scalpel handle, one-piece scalpel, snare, spatula, stapler, disposable or reusable stripper, stylet, suturing apparatus for the stomach and intestine, measuring tape, and calipers. A surgical instrument that has specialized uses in a specific medical specialty is classified in separate regulations in parts 868 through 892.

• Heat and Moisture Condenser (FDA Code: BYD / 868.5375)

A heat and moisture condenser (artificial nose) is a device intended to be positioned over a tracheotomy (a surgically created opening in the throat) or tracheal tube (a tube inserted into the trachea) to warm and humidify gases breathed in by a patient.