CooperVision Manufacturing Ltd
United Kingdom GB-MF-000021104 Last updated 25 Oct 2026
- Devices
- 21
- Registries
- EUDAMEDFDA
- FDA recalls
- 0
Catalogue
EUDAMED certificates
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
Related companies
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.
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.
Information
- Country
- United Kingdom
- Address
- South Point, Hamble, Southampton, United Kingdom (ex Northern Ireland)
- Website
- coopervision.co.uk/
- [email protected]
- PRRC contact
- Stuart Andrews
- EUDAMED SRN
- GB-MF-000021104
- FDA FEI number
- 3006514242