NIDEK.CO.Ltd.

Certificate 4202074CE04

Rev. 5Amended

Valid until: Nov 1, 2026

Certificate 4202074CE04 — a Quality management system issued to NIDEK.CO.Ltd. — is approaching its expiry. Valid until November 1, 2026. View the full certificate record on MD Atlas.

Overview

Certificate number: 4202074CE04
Certificate type: Quality management system
Certificate status: Amended
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 03444202074CE045

Validity

Issued: Oct 30, 2025
Valid from: Oct 30, 2025
Valid until: Nov 1, 2026

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

Status changes

Amended

Supersedes

4202074CE04SupplementedOct 30, 2025 → Nov 1, 2026

Predecessor certificate not registered in EUDAMED.

Scope coverage

Class IIb2

2 scopes

DEVICE
Class IIb
DEVICE
Class IIb

Documents

LanguagesEN