Gofarm Sp. z o.o. Sp. k.

Certificate 1434-MDR-042/2025

Rev. 1/05.11.2025/S/015/BM/2023Issued

Valid until: Nov 5, 2030

Certificate 1434-MDR-042/2025 is a valid Quality management system issued to Gofarm Sp. z o.o. Sp. k. and registered in EUDAMED. Valid until November 5, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 1434-MDR-042/2025
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 14341434-MDR-042/20251/05.11.2025/S/015/BM/2023

Validity

Issued: Nov 5, 2025
Valid from: Nov 5, 2025
Valid until: Nov 5, 2030

Notified body

Notified body: POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A.
Notified body SRN: 1434
Notified body country: Poland

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: Yes
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

M9002 - PROTECTIVE DEVICES, LUBRICANTS AND SOOTHING DEVICES (SPRAYS, GELS, FLUIDS AND CREAMS)
Class IIa
Specjalistyczny krem do rąk i stóp / Specialistic hands and feet cream
Class IIa
Specjalistyczny żel na skórę / Specialistic skin gel
Class IIa
Specjalistyczny spray na skórę / Specialistic skin spray
Class IIa