STE PHARMACEUTICALS, S.L.U

Certificate 002/MDR

Rev. 17Supplemented

Valid until: Dec 4, 2030

Certificate 002/MDR is a valid Quality assurance issued to STE PHARMACEUTICALS, S.L.U and registered in EUDAMED. Valid until December 4, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 002/MDR
Certificate type: Quality assurance
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0051002/MDR17

Validity

Issued: Jun 24, 2026
Valid from: Jun 24, 2026
Valid until: Dec 4, 2030

Manufacturer

Manufacturer: STE PHARMACEUTICALS, S.L.U
Manufacturer SRN: ES-MF-000000144
Manufacturer country: Spain

Notified body

Notified body
Notified body SRN: 0051
Notified body country: Italy

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

002/MDRSupplementedApr 22, 2026 → Dec 4, 2030

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIa5

5 scopes

Dispositivo medico in forma liquida per il trattamento della tosse / Medical device in liquid form for the treatment of cough
Class IIa
Soluzione per irrigazione nasale in spray / Spray solution for nasal irrigation
Class IIa
Soluzione per irrigazione auricolare in spray / Spray solution for ear irrigation
Class IIa
Soluzione ceruminolitica / Ceruminolytic solution
Class IIa
Soluzione in spray per la riduzione dei sintomi causati da irritazione del condotto uditivo esterno / Spray solution for the reduction of the symptoms caused by irritation of the external ear canal
Class IIa

Documents

LanguagesENIT