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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: andropenis
Classification Name: DEVICE, EXTERNAL PENILE RIGIDITY
Product Code: LKY
Device Class: 2
Regulation Number: 876.5020
Medical Specialty: Gastroenterology
Registered Establishment Name: ANDROMEDICAL SL
Registered Establishment Number: 3006891790
Owner/Operator: ANDROMEDICAL SL
Owner/Operator Number: 10024070
Establishment Operations: Manufacturer
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