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Urotronic, Inc.

United States·US-MF-000011144

Last updated September 17, 2026

Information

Country: United States
Address: 2495 Xenium Lane N, Minneapolis, United States
Website: urotronic.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1-7632857484
PRRC Contact: Nicole Boser
EUDAMED SRN: US-MF-000011144
FDA FEI Number: 3015228875
DUNS Number: 080558603

Catalogue (27)

Device	Model / Reference	Registries	Class	Status
Optilume BPH Catheter System	1189	FDA UDI	Class III	Active
Optilume BPH Catheter System	1189	FDA UDI	Class III	Active
Optilume Basic Urological Dilation catheter	1147	FDA UDI	Class II	Active
Optilume Basic Urological Dilation catheter	1147	FDA UDI	Class II	Active
Optilume BPH Catheter System	1189	FDA UDI	Class III	Active
Optilume BPH Drug Coated Balloon Catheter	1113	FDA UDI	Class III	Active
Optilume BPH Pre-dilation Catheter	1137	FDA UDI	Class III	Active
Optilume BPH Drug Coated Balloon Catheter	1113	FDA UDI	Class III	Active
Optilume Urethral Drug Coated Balloon	1110	FDA UDI	Class III	Active
Optilume BPH Drug Coated Balloon Catheter	1113	FDA UDI	Class III	Active
Optilume BPH Drug Coated Balloon Catheter	1113	FDA UDI	Class III	Active
Optilume Basic Urological Dilation catheter	1147	FDA UDI	Class II	Active
Optilume Basic Urological Dilation catheter	1147	FDA UDI	Class II	Active
Optilume Urethral Drug Coated Balloon	1110	FDA UDI	Class III	Active
Optilume BPH Catheter System	1189	FDA UDI	Class III	Active
Optilume Urethral Drug Coated Balloon	1110	FDA UDI	Class III	Active
Optilume Basic Urological Dilation catheter	1147	FDA UDI	Class II	Active
Optilume Urethral Drug Coated Balloon	1110	FDA UDI	Class III	Active
Optilume BPH Pre-dilation Catheter	1137	FDA UDI	Class III	Active
Optilume Urethral Drug Coated Balloon	1110	FDA UDI	Class III	Active
Optilume Urethral Drug Coated Balloon	1110	FDA UDI	Class III	Active
Optilume Urethral Drug Coated Balloon	1110	FDA UDI	Class III	Active
Optilume Basic Urological Dilation catheter	1147	FDA UDI	Class II	Active
Optilume Basic Urological Balloon Dilation Catheter	K191061	EUDAMEDFDA 510(k)	Class II	Active
Optilume® High Pressure Urological Balloon Dilation Catheter	K250910	FDA 510(k)	Class II	Active
Optilume Urethral Drug Coated Balloon	P210020	FDA PMAFDA UDI	Class III	Active
Optilume™ BPH Catheter System	P220029	FDA PMA	Class III	Active

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