Data / Medical devices / United Kingdom / Coopervision Manufacturing, Ltd.
Coopervision Manufacturing, Ltd.: FDA-registered device maker in EASTLEIGH Hampshire, United Kingdom, 3 510(k) clearances and 1 PMA approval
Coopervision Manufacturing, Ltd. is registered with the FDA (registration 3003981983) in EASTLEIGH Hampshire, United Kingdom. It lists 3 device types. The FDA files 3 510(k) clearances and 1 PMA approval under its listings, the newest dated February 4, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3003981983
- Address
- Chandlers Ford, Erith House, Warrior Close, EASTLEIGH Hampshire, United Kingdom, SO53 4TE
- Owner or operator
- COOPERVISION, INC. (9929062)
- Roles
- Manufacturer
- First device listed
- November 15, 2007
- Registered through
- 2026
- Brand names listed
- MyDay Asphere, MyDay Energys, MyDay Multifocal, MyDay Toric, Pearle Vision 1-day Premium Multifocal
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Daily Wear Soft Contact Lens To Reduce The Progression Of Myopia | QIT | 3 | Manufacturer | accessdata.fda.gov |
| Lens, Contact, (Disposable) | MVN | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 4, 2022 | K220070 | MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| August 30, 2013 | K131378 | SUS (STENFILCON A) CONTACT LENS | LPL | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
| November 22, 2006 | K061948 | PROCLEAR (OMAFILCON A) DAILY DISPOSABLE/DAILY WEAR SOFT CONTACT LENS | MVN | Substantially Equivalent | CooperVision, Inc. | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| November 15, 2019 | P180035 | MiSight 1 Day (omafilcon A) Soft (Hydrophilic) Contact Lenses for Daily Wear | QIT | 34 | February 17, 2026 | accessdata.fda.gov |
Compare with other makers
Updated February 17, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.