Gyrus ACMI, Inc.

SRN US-MF-000034237

manufacturer · Brooklyn Park, MN, US · 603 devices

9600 Louisiana Ave. North,, 55445

Devices

Name	UDI-DI	Class	Badge
SB2975SC	00821925035508	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SB4000SA	00821925027909	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SB4000SC	00821925035515	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SB4015SC	00821925035522	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SB4040RC	00821925035539	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SB4040SC	00821925035546	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SB4060RC	00821925035553	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SB4060SC	00821925035560	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SB4075RC	00821925043213	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SB4090RC	00821925035577	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
ShockPulse Accessories - power cord, footswitch	00821925043695	Class I	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
ShockPulse Accessories - power cord, footswitch	00821925043718	Class I	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
ShockPulse lithotripsy accessories (nosecone, wrench, stylet)	00821925039445	Class I	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
ShockPulse lithotripsy accessories (nosecone, wrench, stylet)	00821925043671	Class I	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
ShockPulse lithotripsy accessories (nosecone, wrench, stylet)	00821925043701	Class I	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SHOCKPULSE LITHOTRIPSY TRANSDUCER	00821925043831	Class IIb	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Soltive Surgical laser system accessories - footswitches	00821925044258	Class I	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Soltive Surgical laser system accessories - power cord	00821925044463	Class I	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
Soltive Surgical laser system accessories - power cord	00821925044487	Class I	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SPL-G	00821925044203	Class IIb	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SPL-PDBX097	00821925044180	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SPL-PDBX150	00821925044210	Class IIa	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SPL-SR	00821925043824	Class IIb	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SSC4508	00821925031524	Class IIb	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED
SSC4510	00821925031531	Class IIb	No Certificate Found Snapshot 2026-10-31 · Link to EUDAMED