LSI SOLUTIONS, Inc.

Certificate MDR 829377

Rev. R001Supplemented

Valid until: Feb 7, 2028

Certificate MDR 829377 is a valid Quality management system issued to LSI SOLUTIONS, Inc. and registered in EUDAMED. Valid until February 7, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 829377
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 829377R001

Validity

Issued: Jun 9, 2026
Valid from: Jun 9, 2026
Valid until: Feb 7, 2028

Manufacturer

Manufacturer
Manufacturer SRN: US-MF-000008267
Manufacturer country: United States

Notified body

Notified body
Notified body SRN: 2797
Notified body country: Netherlands

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

MDR 829377SupplementedApr 21, 2026 → Feb 7, 2028

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class I4Class IIa1Class III1

6 scopes

Single-Use Suture Instruments
Class IIa
COR-KNOT Technology Product Line
Class III
multiSTATION Product Family
Class I
VALVEVAULT Device
Class I
RAM RING/RAM RACK Product Family
Class I
SEW-EASY Product Family
Class I

Documents

LanguagesEN