ChongQing Sunkingdom Medical Instrument Co. Ltd

Certificate FI23/1008004

Rev. Issue 1Issued

Valid until: Dec 27, 2028

Certificate FI23/1008004 is a valid Quality management system issued to ChongQing Sunkingdom Medical Instrument Co. Ltd and registered in EUDAMED. Valid until December 27, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: FI23/1008004
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0598FI23/1008004Issue 1

Validity

Issued: Dec 28, 2023
Valid from: Dec 28, 2023
Valid until: Dec 27, 2028

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

Z12120122 Tonometers
Class IIa
Non-contact tonometer model: SK-5000A
Class IIa
Non-contact tonometer model: SK-5000B
Class IIa

Documents

LanguagesEN