OKEAN ZALE S.L

Certificate 2025 PR 0048

Rev. 2Issued

Valid until: Apr 14, 2030

Certificate 2025 PR 0048 is a valid Quality assurance issued to OKEAN ZALE S.L and registered in EUDAMED. Valid until April 14, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 2025 PR 0048
Certificate type: Quality assurance
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03182025 PR 00482

Validity

Issued: Nov 25, 2025
Valid from: Nov 25, 2025
Valid until: Apr 14, 2030

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: No
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: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa4

4 scopes

MDA 0307: Productos activos no implantables respiratorios / Active non-implantable respiratory devices
Class IIa
OZ Hypertonic nasal spray
Class IIa
OZ Istonic nasal spray
Class IIa
OZ Pediatric nasal spray
Class IIa