Jiangxi ZhuoRuiHua Medical Instrument Co.,Ltd.

Certificate HZ 2144705-1

Rev. 0Issued

Valid until: May 28, 2030

Certificate HZ 2144705-1 is a valid Quality management system issued to Jiangxi ZhuoRuiHua Medical Instrument Co.,Ltd. and registered in EUDAMED. Valid until May 28, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2144705-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2144705-10

Validity

Issued: May 29, 2025
Valid from: May 29, 2025
Valid until: May 28, 2030

Notified body

Notified body: TÜV Rheinland LGA Products GmbH
Notified body SRN: 0197
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

Sterile: Yes
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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa1Class IIb1

2 scopes

G030301 - POLYPECTOMY SNARES
Class IIa
G030202 - DIGESTIVE ENDOSCOPY, HAEMOSTASIS DEVICES DIGESTIVE ENDOSCOPY, HAEMOSTASIS CLIPS
Class IIb

Documents

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