Herb-Pharma Corporation s.r.o.

Certificate 2024-MDR/QS-023/B

Rev. 02Supplemented

Valid until: Apr 18, 2029

Certificate 2024-MDR/QS-023/B is a valid Quality management system issued to Herb-Pharma Corporation s.r.o. and registered in EUDAMED. Valid until April 18, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: 2024-MDR/QS-023/B
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 22652024-MDR/QS-023/B02

Validity

Issued: Jan 26, 2026
Valid from: Jan 26, 2026
Valid until: Apr 18, 2029

Notified body

Notified body: 3EC International a.s.
Notified body SRN: 2265
Notified body country: Slovakia

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: No
QMS/MOS type: Basic UDI-DI data only

History

Status changes

Supplemented

Supersedes

2024-MDR/QS-023/AQuality management systemIssuedMay 19, 2025 → Apr 18, 2029

Scope coverage

Class IIa6

6 scopes

fytofontana VIROSTP oral spray
Class IIa
fytofontana VIROSTP nasal spray
Class IIa
fytofontana VIROSTP pastilles
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN