COOPERVISION MANUFACTURING, LTD.

Reg #: 9614392 · FEI: 3002806417 · Expires 2026

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Products

Proprietary Names

Establishment Types

Classifications

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Registration Details

Registration Name: COOPERVISION MANUFACTURING, LTD.
Registration Number: 9614392
FEI Number: 3002806417
Status: Active
Expiry Year: 2026
Initial Importer: No
Address: SOUTHPOINT, HAMBLE, UNIT 2
City: SOUTHAMPTON Hampshire
Country: GB

Regulatory Submissions

510(k) Number: K220070
PMA Number: P080011

Owner / Operator

Firm Name: COOPERVISION, INC.
Operator Number: 9929062
Address: 6101 Bollinger Canyon Road, Suite 500
City: San Ramon
State: CA
Postal Code: 94583
Country: US

US Agent

Business Name: COOPERVISION, INC.
Contact Name: Annette Nelson
Address: 6101 Bollinger Canyon Road, Suite 500
City: San Ramon
State: CA
ZIP: 94583
Country: US
Email: [email protected]
Phone: 925 6604471

Products

Device Name	Product Code	Device Class	Medical Specialty	Exempt	Created
Lenses, Soft Contact, Daily Wear	LPL	Class 2	Ophthalmic	No	2024-01-17
Lens, Contact, (Disposable)	MVN	Class 2	Ophthalmic	No	2024-01-17
Lenses, Soft Contact, Extended Wear	LPM	Class 3	Ophthalmic	No	2008-12-23

Proprietary Names

Pearle Vision 1-day Premium Multifocal MyDay Energys MyDay Multifocal MyDay Toric MyDay Asphere Softmed Breathables Advanced Toric BIOFINITY XR BIOFINITY MULTIFOCAL BIOFINITY TORIC Biofinity Biofinity Energys Biofinity XR Toric Biofinity XR Multifocal BIOFINITY TORIC MULTIFOCAL Avaira Vitality Toric Avaira Vitality Sphere

Establishment Types

Manufacture Medical Device Complaint File Establishment per 21 CFR 820.198