Beijing Wanliandaxinke Instruments Co., Ltd.

Certificate G15 121793 0004

Rev. Rev. 00Issued

Valid until: Oct 8, 2030

Certificate G15 121793 0004 is a valid Quality management system issued to Beijing Wanliandaxinke Instruments Co., Ltd. and registered in EUDAMED. Valid until October 8, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: G15 121793 0004
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G15 121793 0004Rev. 00

Validity

Issued: Oct 9, 2025
Valid from: Oct 9, 2025
Valid until: Oct 8, 2030

Manufacturer

Manufacturer: Beijing Wanliandaxinke Instruments Co., Ltd.
Manufacturer SRN: CN-MF-000019759
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0123
Notified body country: Germany

Covered devices

No specific devices are listed for this certificate.

Characteristics

: No
: No
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: Yes
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: Yes
: Yes
: No
: No
: No

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb4Class IIa2

6 scopes

The Airway Adapter is a necessary accessory for mainstream respiratory monitoring hosts, connected in series with the respiratory tubing. The patient's respiratory gas passes through the airway adapter and, through its optical window, cooperates with mainstream monitoring modules to monitor vital sign parameters such as carbon dioxide concentration, respiratory rate, and anesthetic gas concentration in real time.
Class IIa
"Multi-parameter Patient Monitor monitors and displays Patient physiological parameters in real-time during anesthesia, recovery, and respiratory care, and alerts, while providing relevant waveforms and data. Suitable for operating rooms, wards, ICUs, emergency, transportation, respiratory care etc. The applicable population includes adult, adolescent, child, small child and infant.
Class IIb
The Carbon Dioxide Sensor is a part of the monitoring system, used in conjunction with the monitoring device host to monitor the patient's end expiratory carbon dioxide concentration and respiratory rate in real time, and provide waveforms and data. Suitable for operating rooms, wards, ICUs, emergency, transportation, respiratory care etc. The applicable population includes adult, adolescent, child, small child and infant.
Class IIb
Carbon Dioxide Monitor measures, displays and monitors carbon dioxide partial pressure and respiratory rate during anesthesia, recovery and respiratory care in real-time during, provide waveforms and data. and it has an alarm function. Suitable for operating rooms, wards, ICUs, emergency, transportation, respiratory care etc. The applicable population includes adult, adolescent, child, small child and infant.
Class IIb
The Multi-gas Sensor is a part of the monitoring system, used in conjunction with the monitoring equipment host to monitor the real-time respiratory rate and content of CO2, N2O, as well as the content of anesthetics such as halothane, isoflurane, enflurane, sevoflurane, and desflurane in the mixed gas, and be avalible in various parameter configurations. Provide waveforms and data. Suitable for operating rooms, wards, ICUs, emergency, transportation, respiratory care etc.
Class IIb
Gas Sampling Line used in conjunction with the monitoring and measurement host as a respiratory gas pipeline, for sampling and transmitting gas to the host, in conjunction with monitoring the concentration of carbon dioxide, respiratory rate, anesthesia gas concentration, etc. in the exhaled gas of patients. Suitable for operating rooms, wards, ICUs, emergency, transportation, respiratory care etc. The applicable population includes adult, adolescent, child, small child and infant.
Class IIa

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