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CooperVision Manufacturing Ltd

United Kingdom GB-MF-000021104 Last updated 25 Oct 2026

Devices
21
Registries
EUDAMEDFDA
FDA recalls
0

Catalogue21

EUDAMED certificates1

Held under this manufacturer's EUDAMED registration, grouped by notified body; in force first, then by expiry.

EUDAMED certificates (1)

TÜV SÜD Product Service GmbH 0123 1 certificate

  • G10 103773 0009 Issued

    Quality management system EU MDR

    Issued
    14 Mar 2025
    Expires
    13 Mar 2030

Notified bodies

What CooperVision Manufacturing Ltd makes

CooperVision Manufacturing Ltd produces daily disposable contact lenses designed for vision correction, including multifocal, aspheric, toric, and myopia management options. These lenses are formulated with materials like somofilcon A and stenfilcon A for extended wear comfort and optical clarity.

The company’s portfolio is classified under EU Device Class IIa and is registered in the EUDAMED database. The manufacturer is based in the United Kingdom.

Written from this company's registered devices by an AI model, and not verified by a human reviewer.

Frequently asked questions

What types of medical devices does CooperVision Manufacturing Ltd produce?

CooperVision Manufacturing Ltd specialises in daily disposable contact lenses for vision correction. Their portfolio includes lenses designed for multifocal vision (for presbyopia), astigmatism (toric lenses), myopia control, and standard single-vision correction. These lenses use materials like somofilcon A and stenfilcon A to provide comfort and optical clarity for daily wear.

Where is CooperVision Manufacturing Ltd based?

The company is headquartered in the United Kingdom, specifically in Great Britain. This location is relevant for regulatory compliance and reporting purposes within the EU market.

Which regulatory registries list CooperVision Manufacturing Ltd’s devices?

CooperVision Manufacturing Ltd’s devices are registered in the EUDAMED database, which is the European Union’s centralised registry for medical devices. This registration is required for transparency and traceability under EU medical device regulations.

How are CooperVision Manufacturing Ltd’s devices classified under EU regulations?

All of CooperVision Manufacturing Ltd’s listed devices fall under EU Device Class IIa. This classification is determined by factors like the intended use, potential risks, and duration of contact with the body (in this case, daily disposable contact lenses). Class IIa devices require conformity assessment procedures, including clinical evaluation and risk management, to ensure safety and performance.

AI-generated from registry data and not verified by a human reviewer.

Information

Country
United Kingdom(from SRN)
Address
South Point, Hamble, Southampton, United Kingdom (ex Northern Ireland)
PRRC contact
Stuart Andrews
EUDAMED SRN
GB-MF-000021104
FDA FEI number
3006514242