CATHAY MANUFACTURING CORP.

Certificate HZ 2028375-1

Rev. Rev.1Amended

Valid until: Dec 16, 2029

Certificate HZ 2028375-1 is a valid Quality management system issued to CATHAY MANUFACTURING CORP. and registered in EUDAMED. Valid until December 16, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2028375-1
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 3
Certificate ID: 0197HZ 2028375-1Rev.1

Validity

Issued: Jan 21, 2026
Valid from: Jan 21, 2026
Valid until: Dec 16, 2029

Manufacturer

Manufacturer: CATHAY MANUFACTURING CORP.
Manufacturer SRN: CN-MF-000020725
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: No
Intended medical purpose: No
SPP applicable

History

Status changes

Amended

Supersedes

HZ 2028375-1Quality management systemIssuedDec 17, 2024 → Dec 16, 2029

Scope coverage

Class IIb1

1 scope

K020102- MONO- AND BIPOLAR DEVICES, SINGLE-USE ELECTROSURGERY PADS (NEUTRAL ELECTRODES) AND CABLES, SINGLE-USE Disposable Neutral Electrodes
Class IIb

Documents

LanguagesEN