Shenzhen Comen Medical Instruments Co.,LTD.

Certificate FI23/1008002

Rev. Issue 7Supplemented

Valid until: Sep 5, 2028

Certificate FI23/1008002 is a valid Quality management system issued to Shenzhen Comen Medical Instruments Co.,LTD. and registered in EUDAMED. Valid until September 5, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: FI23/1008002
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 7
Certificate ID: 0598FI23/1008002Issue 7

Validity

Issued: Dec 23, 2025
Valid from: Dec 23, 2025
Valid until: Sep 5, 2028

Manufacturer

Manufacturer: Shenzhen Comen Medical Instruments Co.,LTD.
Manufacturer SRN: CN-MF-000002236
Manufacturer country: China

Notified body

Notified body
Notified body SRN: 0598
Notified body country: Finland

Covered devices

Characteristics

Sterile: No
Human tissues: No
Animal tissues: No
In vitro diagnostics: No
Initial registration: No
New device: No
Discard allowed: No
SSCP enabled: Yes
Mechanism of scrutiny: Yes
Intended medical purpose: No
SPP applicable

History

Status changes

Supplemented

Supersedes

FI23/1008002Quality management systemSupplementedNov 22, 2025 → Sep 5, 2028

Scope coverage

Class IIb22Class IIa17

39 scopes

EMDN: Z12020511 Video gastroscopes
Class IIa
EMDN: Z12020606 Video colonoscopes
Class IIa
EMDN: Z12020802 Video bronchoscopes
Class IIa
EMDN: Z12020402 Light sources for endoscopy and minimally invasive surgery
Class IIa
EMDN: Z12020406 Video processors
Class IIa
EMDN R060201 Active Ventilation Humidification System
Class IIa
EMDN: Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
Class IIb
EMDN: Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
Class IIb
EMDN: Z1203010504 Adult and paediatric/neonatal pulmonary ventilators
Class IIb
EMDN: Z1203010503 Neonatal/pediatric pulmonary ventilators
Class IIb
EMDN: Z12030102 Continuous positive pressure equipment
Class IIb
EMDN: Z12030104 Portable pulmonary ventilators
Class IIb
Z1203019099 Various instruments for anaesthesia and pulmonary ventilation support other
Class IIb
EMDN: Z12030502 Manual defibrillators
Class IIb
Respiratory Humidifier, Models: HT50, HT30, Basic UDI-DI: 69454290RH001NV
Class IIa
DEVICE
Class IIb
DEVICE
Class IIb
Neonatal Ventilator NV7, NV8, NV9, Basic UDI-DI: 69454290NV001QK
Class IIb
DEVICE
Class IIb
Ventilator Models V3, V3A, V3B, V3C, V3D, V3 Pro, V3A Pro, V3B Pro Basic UDI-DI: 69454290GV001N6
Class IIb

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