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AMAR · registration 3020769Expired

Ambu Duodeno System: AMBU aScope Duodeno, AMBU aBox Duodeno

IsraelAmbu A/S
Official record identity
AMAR registration number
3020769
Expiry date
July 01, 2026
Status
Expired
Published parties
Manufacturer
Ambu A/S
Manufacturer country
Denmark
Official value: DENMARK
Official description

The aBox Duodeno is designed to be used with the aScope Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade video monitor) for endoscopy and endoscopic surgery within the duodenum. The aBox Duodeno is intended to process the camera data of a connected duodenoscope during Endoscopic retrograde cholangiopancreatography(ERCP) and to make this data and a graphical user interface available to a connected monitor. The device also includes an irrigation pump to ensure the irrigation function of the connected endoscope. The aBox Duodeno is designed for professional users; operators of the system are physicians trained in diagnostic and therapeutic GI Endoscopy; the operators can be assisted by trained medical staff e.g. endoscopy nurses. The aBox Duodeno is intended for use in a clinical environment (Hospitals, GI-suites). The aScope Duodeno is designed to be used with the aBox Duodeno, endoscopic accessories (e.g. biopsy forceps) and other ancillary equipment (e.g. medical grade, video monitor) for endoscopy and endoscopic surgery within the duodenum. The aScope Duodeno is intended for Endoscopic retrograde cholangiopancreatography (ERCP) procedures and is used primarily to diagnose and treat conditions of the bile ducts and main pancreatic duct, including gallstones, inflammatory strictures (scars), leaks (from trauma and cancer. ERCP can be performed for diagnostic and therapeutic reasons. The aScope Duodeno is designed for professional users; operators of the system are physicians trained in diagnostic and therapeutic GI Endoscopy; the operators can be assisted by trained medical staff e.g. endoscopy nurses. The aScope Duodeno is intended for use in a clinical environment (Hospitals, GI-suites).

Additional source fields
Official Hebrew product name
אמבו דואדנו סיסטם
Published operator
רופא/ה
Published place of use
בית חולים
Published expertise
אחר
About this record

This page mirrors one result from the Ministry of Health AMAR registry. The official English name is displayed when supplied, with the Hebrew name preserved as source evidence. Manufacturer, registered owner, category, country, and expiry retain their source meanings. Region-like country values are not guessed into a country code.