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BQ Plus Medical Co., Ltd.

Certificate HZ 2087599-1

Rev. 0Issued
Valid until
Jun 2, 2030

Certificate HZ 2087599-1 is a valid Quality management system issued to BQ Plus Medical Co., Ltd. and registered in EUDAMED. Valid until June 2, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number
HZ 2087599-1
Certificate type
Quality management system
Certificate status
Issued
Applicable legislation
MDR [Regulation (EU) 2017/745 on medical devices]
Version
1
Certificate ID
0197HZ 2087599-10

Validity

Issued
Jun 3, 2025
Valid from
Jun 3, 2025
Valid until
Jun 2, 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
No
Intended medical purpose
No
SPP applicable
No
Conditions applicable
No
MOS outside EUDAMED
—
QMS/MOS type
Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class I2Class IIa1

3 scopes

  • A030101 - INFUSION CONTROLLERS A030201 - EXTENSIONS A070103 - INFUSION LINES ADAPTERS AND CONNECTORS A070502 - CAPS OR OBTURATORS, PERFORABLE A030103 - ENTERAL FEEDING CONTROLLERS A020108 - ENTERAL FEEDING SYRINGES
    Class I
  • R030101 - VENTILATION MASKS A030103 - ENTERAL FEEDING CONTROLLERS A030101 - INFUSION CONTROLLERS
    Class IIa
  • A020108 - ENTERAL FEEDING SYRINGES A030103 - ENTERAL FEEDING CONTROLLERS A030101 - INFUSION CONTROLLERS
    Class I

Documents

LanguagesEN

Manufacturer

Manufacturer
BQ Plus Medical Co., Ltd.
Manufacturer SRN
CN-MF-000010259
Manufacturer country
China