Shenzhen Jermei Medical Device Technology Co.,Ltd.

Certificate FI26/1008024

Rev. Issue 1Issued

Valid until: May 5, 2031

Certificate FI26/1008024 is a valid Quality management system issued to Shenzhen Jermei Medical Device Technology Co.,Ltd. and registered in EUDAMED. Valid until May 5, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: FI26/1008024
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI26/1008024Issue 1

Validity

Issued: May 6, 2026
Valid from: May 6, 2026
Valid until: May 5, 2031

Notified body

Notified body: SGS FIMKO OY
Notified body SRN: 0598
Notified body country: Finland

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: Basic UDI-DI data only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

MDA 0307, MDS 1009, MDT2002, MDT 2010, MDT 2011 EMDN Z12040210 ultrasonic nebulizers 
Class IIa
DEVICE
Class IIa

Documents

LanguagesEN