Shenzhen Boon Medical Supply Co.,Ltd.

Certificate HZ 2158141-1

Rev. 2Supplemented

Valid until: Jul 2, 2028

Certificate HZ 2158141-1 is a valid Quality management system issued to Shenzhen Boon Medical Supply Co.,Ltd. and registered in EUDAMED. Valid until July 2, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2158141-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2158141-12

Validity

Issued: May 8, 2025
Valid from: May 8, 2025
Valid until: Jul 2, 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: No
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

Status changes

Supplemented

Supersedes

HZ 2158141-1Quality management systemIssuedDec 8, 2023 → Jul 2, 2028

Scope coverage

Class IIa1

1 scope

A0299 - SYRINGES – OTHER - Sterile High-pressure Angiographic Syringes for Multi-use A02010401 - SYRINGES FOR CONTRAST MEDIA INJECTOR, SINGLE-USE - Single-use Sterile High-pressure Angiographic Syringes and Accessories A03020102 - HIGH PRESSURE EXTENSION LINES - Pressure Connecting Tubes for Single use - Multi-Use Tubing System Kits
Class IIa

Documents

LanguagesEN