Shenzhen Comen Medical Instruments Co.,LTD.

Certificate CN23/00001577

Rev. 13Supplemented

Valid until: Mar 31, 2028

Certificate CN23/00001577 is a valid Quality management system issued to Shenzhen Comen Medical Instruments Co.,LTD. and registered in EUDAMED. Valid until March 31, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: CN23/00001577
Certificate type: Quality management system
Certificate status: Supplemented
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 11
Certificate ID: 1639CN23/0000157713

Validity

Issued: Apr 14, 2025
Valid from: Apr 14, 2025
Valid until: Mar 31, 2028

Manufacturer

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

Notified body

Notified body
Notified body SRN: 1639
Notified body country: Belgium

Covered devices

Characteristics

Sterile: Yes
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

CN23/00001577Quality management systemAmendedMar 12, 2025 → Mar 31, 2028

Scope coverage

Class IIb28Class IIa6Class III2

36 scopes

MDA0316
Class IIa
MDA0203, MS1009, MDS1010 - EMDN: Z120302
Class IIb
MDA0306, MDS1009, MDS1010, EMDN:Z12030302
Class IIb
MDA0306 MDS1004 MDS1005 MDS1009 EMDN Z1203 0101
Class IIb
MDA0305, MDS1009, MDS1010
Class III
MDA0316 MDS1009 MDS1004 EMDN: Z129007
Class IIb
MDA0315, MDS1009, MDS1010 EMDN: Z120302
Class IIb
MDA0305 MDS1009
Class IIa
Electrocardiograph (CM1200, CM1200A, CM1200B, H3;H12, H12A)
Class IIa
Infrared Ear Thermometer (IRT10, IRT10A)
Class IIa
DEVICE
Class IIb
Ceiling Pendant D5, D6, D7. D8. D9 D9A
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb
DEVICE
Class IIb

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