Zhejiang Hongyu Medical Commodity Co.,Ltd

Certificate HZ 2253563-1

Rev. 0Issued

Valid until: Dec 16, 2030

Certificate HZ 2253563-1 is a valid Quality management system issued to Zhejiang Hongyu Medical Commodity Co.,Ltd and registered in EUDAMED. Valid until December 16, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2253563-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2253563-10

Validity

Issued: Dec 17, 2025
Valid from: Dec 17, 2025
Valid until: Dec 16, 2030

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: Yes
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Class IIb only

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I1Class IIb1

2 scopes

M040101 - ADHESIVE DRESSINGS, WITH ABSORBENT PAD M040102 - FIXING DRESSINGS T020603 - MEDICAL USE FACE MASKS, TYPE I (NOT FOR HEALTHCARE PROFESSIONALS) T020604 - MEDICAL USE FACE MASKS, TYPE II AND IIR M0299 - GAUZES - OTHER M030101 - HYDROPHILIC GAUZE BANDAGES M03030299 - PROTECTION SYSTEMS – OTHER V0799 – PRODUCTS FOR CLEANING MEDICAL DEVICES NOT INCLUDED IN OTHER CLASSES-OTHER M040204 - NON-ADHERENT ABSORBENT DRESSINGS
Class I
M040407 - DRESSINGS FOR WOUNDS, SORES AND ULCERATIONS SILICONE DRESSINGS
Class IIb

Documents

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