FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD

Certificate FI25/1008010

Rev. Issue 1Issued

Valid until: Mar 3, 2030

Certificate FI25/1008010 is a valid Quality management system issued to FOSHAN SAFETY MEDICAL EQUIPMENT CO.,LTD and registered in EUDAMED. Valid until March 3, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: FI25/1008010
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI25/1008010Issue 1

Validity

Issued: Mar 4, 2025
Valid from: Mar 4, 2025
Valid until: Mar 3, 2030

Notified body

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

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 IIa3

3 scopes

Dental units - Q0199 ODONTOLOGY DEVICES-OTHER
Class IIa
Dental unit, Models: Mare, Mare.1, Mare.2, Mare.3, Mare.4, Mare.5
Class IIa
Dental Unit, Models: M1, M1+, M2, M2+, M3, M3+, M4, M4+, M5, M5+, M6, M6+, M7, M7+, M8, M8+, M9, M9+, M10, M10+
Class IIa

Documents

LanguagesEN