Ningbo David Medical Device Co., Ltd.

Certificate G10 032913 0046

Rev. Rev. 01Supplemented

Valid until: Feb 28, 2029

Certificate G10 032913 0046 is a valid Quality management system issued to Ningbo David Medical Device Co., Ltd. and registered in EUDAMED. Valid until February 28, 2029. View the full certificate record on MD Atlas.

Overview

Certificate number: G10 032913 0046
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 0123G10 032913 0046Rev. 01

Validity

Issued: May 29, 2026
Valid from: May 29, 2026
Valid until: Feb 28, 2029

Manufacturer

Manufacturer: Ningbo David Medical Device Co., Ltd.
Manufacturer SRN: CN-MF-000009962
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

Sterile: No
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

History

Status changes

Supplemented

Supersedes

G10 032913 0046IssuedMar 1, 2024 → May 28, 2026

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb5Class IIa2

7 scopes

Z120804 - NEONATOLOGY INSTRUMENTS
Class IIb
Z12080401 - PAEDIATRIC PHOTOTHERAPY EQUIPMENT Z12080410 - TRANSCUTANEOUS BILIRUBINOMETERS
Class IIa
Z1203020202 - TRANSPORTABLE/PORTABLE MULTI PARAMETER PATIENT MONITORS
Class IIb
Z12030102 - CONTINUOUS POSITIVE PRESSURE EQUIPMENT
Class IIb
Z1203019099 - VARIOUS INSTRUMENTS FOR ANAESTHESIA AND PULMONARY VENTILATION SUPPORT – OTHER
Class IIa
Z12159004 - OXYGEN CONCENTRATORS
Class IIb
Z12080499 - NEONATOLOGY INSTRUMENTS - OTHER
Class IIb

Documents

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