Profile: Ewald Bacher Medizintechnik Gmbh is a manufacturer of endoscopy accessories that includes forceps, scissors for gastrology, enterology, bronchoscopy, coloscopy & urology. Our product line includes biopsy-forceps, foreign body forceps, polyp-retriever, scissors, insulated forceps & hot biopsy forceps.
The company is ISO 13485:2003 certified.
FDA Registration Number: 1000343527
US Agent: Franz Menean / Medagent, Inc.
Phone: +1-(603)-570-2039 Fax: +1-(603)-570-2055 E-Mail:
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• Gastrointestinal Mechanical Biopsy Instrument (FDA Code: FCF / 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. |