Statistics for Scope Ophthalmics Ltd

4Total Devices

3Basic UDI-DIs

0Not destined for EU market

0Certificates

0Valid

0Expiring < 6 months

1Countries

Certificate health for Scope Ophthalmics Ltd

No certificates registered for this manufacturer.

Showing 1–4 of 4 devices.

Trade name	Reference / catalog number	UDI-DI code	Quantity	Status
Fusion Allergy	`FRFUSION-COOL MASK`	`05391531760392`	1	On the market
Optase Cooling Mask	`FROPTASE-COOL MASK`	`05391531760644`	1	On the market
Optase® Moist Heat Mask	`FROPTASE-MHM`	`05392000104228`	1	On the market
FROPTASE-HMPro	`FROPTASE-HMPro`	`05391531761788`	1	On the market

Devices placed in 1 country

EUDAMED update: Jan 24, 2025

IE-MF-000037510

Active

Address: SUITE 5, WILLOW ROAD WESTLAND HOUSE, WESTLAND PARK D12 Y012 DUBLIN IRELAND
Phone: + 353 1 525 3683
Email: quality.regulatory@scopeeyecare.com
Website: www.scopeeyecare.com

FREYNE Tom
The responsibilities of the PRRC are described in Article 15 of EU MDR 2017/745: The conformity of the devices is properly checked, in accordance with the quality management system under which the devices are manufactured before a device is released. The technical documentation and the EU declaration of conformity are drawn up and kept up to date. The post-market surveillance obligations are complied with in accordance with the requirement of the MDR. Reporting obligations are fulfilled.
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