inforMED
FEI 3027545377

Swav Cr Srl

Coyol Free Zone, Alajuela, CR

MDR events0All time
Recalls0All time
Registered products2
Establishment typeRepackRepack or Relabel Medical Device

Registered product codes

2 product codes

Recent MDR events

0 on file

No MDR events on file for this firm name.

Recalls

0 on file

No recalls on file for this firm name.

Compliance history

Matched by FEI 3027545377.

FDA inspections

2 on file

  • No Action Indicated (NAI)Aug 1, 2024

    Compliance: Devices

  • No Action Indicated (NAI)Aug 1, 2024

    Postmarket Assurance: Devices

Inspection citations

0 on file

No citations on file for this FEI number.

Compliance actions

0 on file

No warning letters or injunctions on file for this FEI number.

Import refusals

1 on file

  • Division of Southeast Imports (DSEI)May 18, 2026

    79PZC \ ABLATION SYSTEM, HIGH INTENSITY FOCUS ULTRASOUND (HIFU), SOFT TISSUE