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U.S. Department of Health and Human Services

Establishment Registration & Device Listing
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Proprietary Name: Androgenital; Erect'r; Jes-extender; Maleedge; Proextender; Sizegenetics
Classification Name: DEVICE, EXTERNAL PENILE RIGIDITY
Product Code: LKY
Device Class: 2
Regulation Number: 876.5020
Medical Specialty: Gastroenterology
Registered Establishment Name: DANAMEDIC APS
Registered Establishment Number: 3005401991
Owner/Operator: DanaMedic ApS
Owner/Operator Number: 10060690
Establishment Operations: Manufacturer
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