Meridian Medical d.o.o.

Certificate MDR-001

Rev. 2Amended

Valid until: Mar 22, 2028

Certificate MDR-001 is a valid Quality management system issued to Meridian Medical d.o.o. and registered in EUDAMED. Valid until March 22, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR-001
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 1304MDR-0012

Validity

Issued: Jun 10, 2025
Valid from: Jun 10, 2025
Valid until: Mar 22, 2028

Notified body

Notified body: SLOVENIAN INSTITUTE OF QUALITY AND METROLOGY - SIQ
Notified body SRN: 1304
Notified body country: Slovenia

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

Status changes

Amended

Supersedes

MDR-001Quality management systemIssuedMar 23, 2023 → Mar 22, 2028

Scope coverage

Class IIb3

3 scopes

Neodymium surgical laser
Class IIb
MR Q SLT s
Class IIb
MR Q SLT c
Class IIb

Documents

LanguagesEN