Unolab manufacturing, S.L.

Certificate 2024 CR 0040

Rev. 1Issued

Valid until: Nov 19, 2029

Certificate 2024 CR 0040 is a valid Quality management system issued to Unolab manufacturing, S.L. and registered in EUDAMED. Valid until November 19, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024 CR 0040
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03182024 CR 00401

Validity

Issued: Nov 20, 2024
Valid from: Nov 20, 2024
Valid until: Nov 19, 2029

Notified body

Notified body: CENTRO NACIONAL DE CERTIFICACION DE PRODUCTOS SANITARIOS
Notified body SRN: 0318
Notified body country: Spain

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb4

4 scopes

MDN 1206: Productos no activos y no implantables oftalmológicos / non-active non-implantable ophtalmologic devides
Class IIb
Solución salina / Saline solution
Class IIb
Solución salina Tamponada / Buffered saline solution
Class IIb
Solución humectante / Wetting solution
Class IIb