Xi'an Friendship Medical Electronics Co., Ltd.

Certificate HZ 2185443-1

Rev. 0Issued

Valid until: Nov 12, 2028

Certificate HZ 2185443-1 is a valid Quality management system issued to Xi'an Friendship Medical Electronics Co., Ltd. and registered in EUDAMED. Valid until November 12, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2185443-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2185443-10

Validity

Issued: Nov 13, 2023
Valid from: Nov 13, 2023
Valid until: Nov 12, 2028

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: 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 IIa1

1 scope

Z121002 - NERVOUS SYSTEM MONITORING SYSTEMS Z121004 - ELECTROMYOGRAPHY INSTRUMENTS
Class IIa

Documents

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