NIDEK.CO.Ltd.

Certificate 4202074CE03

Rev. 0Issued

Valid until: Oct 17, 2028

Certificate 4202074CE03 is a valid Quality management system issued to NIDEK.CO.Ltd. and registered in EUDAMED. Valid until October 17, 2028. View the full certificate record on MD Atlas.

Overview

Certificate number: 4202074CE03
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03444202074CE030

Validity

Issued: Oct 17, 2023
Valid from: Oct 17, 2023
Valid until: Oct 17, 2028

Manufacturer

Manufacturer: NIDEK.CO.Ltd.,
Manufacturer SRN: JP-MF-000040151
Manufacturer country: Japan

Notified body

Notified body
Notified body SRN: 0344
Notified body country: Netherlands

Covered devices

Characteristics

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

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIb2

2 scopes

DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN