Topcon Healthcare Solutions EMEA Oy

Certificate 10000473385-PA-NoMA-DNK

Rev. 1Issued

Valid until: Apr 10, 2030

Certificate 10000473385-PA-NoMA-DNK is a valid Quality management system issued to Topcon Healthcare Solutions EMEA Oy and registered in EUDAMED. Valid until April 10, 2030. View the full certificate record on MD Atlas.

Overview

Certificate number: 10000473385-PA-NoMA-DNK
Certificate type: Quality management system
Certificate status: Issued
Applicable legislation: MDR [Regulation (EU) 2017/745 on medical devices]
Version: 1
Certificate ID: 246010000473385-PA-NoMA-DNK1

Validity

Issued: Apr 10, 2025
Valid from: Apr 10, 2025
Valid until: Apr 10, 2030

Notified body

Notified body: DNV Product Assurance AS
Notified body SRN: 2460
Notified body country: Norway

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: No
Intended medical purpose: No
SPP applicable: No
Conditions applicable: No
MOS outside EUDAMED: —
QMS/MOS type: Others

History

No status changes or preceding certificates are recorded.

Scope coverage

Class IIa2

2 scopes

Software for processing, viewing and measurement of ophthalmic clinical data
Class IIa
Harmony Referral System version 3
Class IIa

Documents

LanguagesEN