ELLIPSE MANUFACTURED BY ANDROMEDA MEDIZINISCHE SYSTEME GMBH

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Request for Information Form	Contact Information
Company Name	ANDROMEDA MEDIZINISCHE SYSTEME GMBH
Address	WALLBERGSTRASSE 5
City, State, Zip	TAUFKIRCHEN/POTZHAM,
Country	GM
FDA Owner/Operator Phone	49-89-6141560
FDA Medical Specialty Code	GU - Gastroenterology/Urology
FDA Product Code	FAP
FDA Classification Name	CYSTOMETRIC GAS (CARBON-DIOXIDE) ON HYDRAULIC DEVICE
FDA Device Classification Code	Standards
FDA Regulation Number	876.1620
FDA Common Generic Name	URODYNAMIC SYSTEM
FDA Proprietary Device Name	ELLIPSE
FDA Owner / Operator Number	9028572
FDA Owner / Operator Name	ANDROMEDA MEDIZINISCHE SYSTEME GMBH
FDA Establishment Registration Number	9615012
FDA Registered Establishment Name	ANDROMEDA MEDIZINISCHE SYSTEME GMBH
FDA Operation Code(s)	MM - Manufacturer
FDA Listing Date	03-03-98
FDA Listing Status Code	Active
Differentiation	N/A
Keywords	N/A
Description	N/A
Brochure	N/A
Product Website	N/A

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5	TELEFLEX MEDICAL AVE. INDUSTRIAS NO.5954 PARQUE INDUSTRIAL FINSA NUEVO LAREDO, TAMAULIPAS, 88275 MX 919-544-8000 / 919-433-4829	URODYNAMIC MEASUREMENT SYSTEM	URODYNAMIC RECTAL CATHETER