Tianjin Huahong Technology Co., Ltd.

Certificate HZ 2027260-1

Rev. 1Supplemented

Valid until: Apr 12, 2028

Certificate HZ 2027260-1 is a valid Quality management system issued to Tianjin Huahong Technology Co., Ltd. and registered in EUDAMED. Valid until April 12, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2027260-1
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 2
Certificate ID: 0197HZ 2027260-11

Validity

Issued: Oct 28, 2025
Valid from: Oct 28, 2025
Valid until: Apr 12, 2028

Manufacturer

Manufacturer: Tianjin Huahong Technology Co., Ltd.
Manufacturer SRN: CN-MF-000015849
Manufacturer country: China

Notified body

Notified body
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: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

HZ 2027260-1Quality management systemIssuedApr 13, 2023 → Apr 12, 2028

Scope coverage

Class IIa1Class IIb1

2 scopes

V010402 - LANCETS WITHOUT SAFETY SYSTEMS, SINGLE-USE V010401 - LANCETS WITH SAFETY SYSTEMS, SINGLE-USE A010101 - HYPODERMIC NEEDLES
Class IIa
Z120108 - GENERAL AND MULTIDISCIPLINARY SURGERY INSTRUMENTS INSTRUMENTS FOR ULTRASONIC SURGERY K020201 - DEVICES FOR SURGERY WITH ULTRASONIC GENERATOR, SINGLE-USE ULTRASONIC SURGERY INSTRUMENTS, SINGLE-USE
Class IIb

Documents

LanguagesEN