Baihe Medical Technology (Wuhan) Co., Ltd.

Certificate HZ 2166631-1

Rev. Rev.0Issued

Valid until: Jan 20, 2031

Certificate HZ 2166631-1 is a valid Quality management system issued to Baihe Medical Technology (Wuhan) Co., Ltd. and registered in EUDAMED. Valid until January 20, 2031. View the full certificate record on MD Atlas.

Overview

Certificate number: HZ 2166631-1
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0197HZ 2166631-1Rev.0

Validity

Issued: Jan 21, 2026
Valid from: Jan 21, 2026
Valid until: Jan 20, 2031

Manufacturer

Manufacturer: Baihe Medical Technology (Wuhan) Co., Ltd.
Manufacturer SRN: CN-MF-000025832
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: Yes
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: No
Intended medical purpose: No
SPP applicable

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I1Class IIa1

2 scopes

A060301 - COLLECTION BAGS AND OTHER CONTAINERS FOR DRAINAGES AND FISTULAS, SINGLE USE
Class I
A070103 - INFUSION LINES ADAPTERS AND CONNECTORS A0703 - STOPCOCKS F020199 - ARTERIOVENOUS DIALYSIS LINES FOR HAEMODIALYSIS - HAEMOFILTRATION - HAEMODIAFILTRATION - OTHER U020302 - DOUBLE LOOP URETERAL STENTS
Class IIa

Documents

LanguagesEN