Shenzhen Hawk Medical Instrument Co., Ltd.

Certificate HZ 2183512-1

Rev. Rev.3Supplemented

Valid until: Oct 25, 2028

Certificate HZ 2183512-1 is a valid Quality management system issued to Shenzhen Hawk Medical Instrument Co., Ltd. and registered in EUDAMED. Valid until October 25, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2183512-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 2183512-1Rev.3

Validity

Issued: Feb 12, 2026
Valid from: Feb 12, 2026
Valid until: Oct 25, 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: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
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: No
QMS/MOS type: Class IIb only

History

Status changes

Supplemented

Supersedes

HZ 2183512-1Quality management systemAmendedDec 5, 2025 → Oct 25, 2028

Scope coverage

Class IIa1Class IIb1

2 scopes

Z120303 - INFUSION INSTRUMENTS
Class IIa
Z120303 - INSTRUMENTS TO SUPPORT AND MONITOR VITAL SIGNS INFUSION INSTRUMENTS
Class IIb

Documents

LanguagesEN