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Resoundant

United States·US-MF-000037180

Last updated September 17, 2026

Information

Country: United States
Address: 421, 1st Ave. SW, Rochester, United States
Website: www.resoundant.com/
LinkedIn: —
Facebook: —
Email: [email protected]
Phone: +1 507 322 0011
PRRC Contact: John Hartigan
EUDAMED SRN: US-MF-000037180
FDA FEI Number: 3013695852
DUNS Number: —

Catalogue (15)

Device	Model / Reference	Registries	Class	Status
Resoundant Acoustic Driver System	RESY3002-RESYSAB	FDA UDI	Class II	Active
Active Driver	RESYS4001	FDA UDI	Class II	Active
MREplus	MREplus 3.0.0DKR	FDA UDI	Class II	Unknown
MREplus	MREplus 3.0.0WIN	FDA UDI	Class II	Unknown
Resoundant Flex Passive Driver, Large	REFPDL18	EUDAMEDFDA UDI	Class I	Active
Resoundant Acoustic Driver System	K201389	FDA 510(k)	Class II	Active
MREplus+ Software	K183193	FDA 510(k)	Class II	Active
Resoundant MR Elastography System	RESYS4001-RESYSAB	EUDAMED	Class IIa	Active
Resoundant Active Driver v2	RESYS4001	EUDAMEDFDA UDI	Class IIa	Active
Resoundant Pillow Passive Driver	REFPDAUX	EUDAMEDFDA UDI	Class I	Active
Resoundant Flex Passive Driver, Small	REFPDS19	EUDAMEDFDA UDI	Class I	Active
MR Elastography System	RESYS4001-RESYSAB	EUDAMEDFDA UDI	Class IIa	Active
MRE Phantom Kit	REMREP15	EUDAMED	Class I	Active
Resoundant Passive Driver, Rigid	REPD2000	EUDAMEDFDA UDI	Class I	Active
Hepatogram plus	RESMPLSA	EUDAMEDFDA UDI	Class IIa	Active

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