Guangdong Baihe Medical Technology Co., Ltd

Certificate MDR 737797

Rev. R001Supplemented

Valid until: Oct 21, 2029

Certificate MDR 737797 is a valid Quality management system issued to Guangdong Baihe Medical Technology Co., Ltd and registered in EUDAMED. Valid until October 21, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: MDR 737797
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 2797MDR 737797R001

Validity

Issued: Jun 9, 2026
Valid from: Jun 9, 2026
Valid until: Oct 21, 2029

Notified body

Notified body: BSI Group The Netherlands B.V.
Notified body SRN: 2797
Notified body country: Netherlands

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

Status changes

Supplemented

Supersedes

MDR 737797SupplementedMar 12, 2026 → Oct 21, 2029

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class III2Class IIa1Class IIb1

4 scopes

Drainages and Kits
Class IIa
Disposable Blood Pressure Transducer
Class IIb
Haemodialysis Catheter Kit
Class III
Central Venous Catheter Kit
Class III

Documents

LanguagesEN