Identity
- Trade Name
- OPTI-FREE PUREMOIST EUDAMEDFDA UDI
- Generic Name
- Contact lens wetting solution FDA UDI
- Device Name
- Alcon Lens Care Solutions EUDAMEDOPTI-FREE PUREMOIST Rewetting Drops 12ml FDA UDI
- Model / Reference
- 0003610204 EUDAMEDOPTI-FREE PUREMOIST 12ml FDA UDI
- Description
- OPTI-FREE PUREMOIST Rewetting Drops 12ml FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00300651361919 EUDAMED00300650192316 FDA UDI
- Basic UDI-DI
- 038065GMN000097HL EUDAMED
- FDA Product Code
- LPN FDA UDI
- EMDN Code
- Q02030204 CONTACT LENSES STORING AND CLEANING SOLUTIONS EUDAMED
- GMDN Term
- Contact lens wetting solution FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA UDI
- Regulation Number
- 886.5928 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
EUDAMEDFDA UDI
Single Use
Yes
FDA UDI
Implantable
No
EUDAMEDFDA UDI
Reusable
No
EUDAMED
Contains Latex
No
EUDAMEDFDA UDI
Reprocessed
No
EUDAMED
CMR Substance
Yes
EUDAMED
Human-derived
No
EUDAMED
Human Tissues
No
EUDAMED
Animal Tissues
No
EUDAMED
Endocrine Disruptor
No
EUDAMED
Administering Medicine
No
EUDAMED
Measuring Function
No
EUDAMED
Incorporates Medicinal Product
No
EUDAMED
Prescription Use
No
FDA UDI
Over-the-Counter
Yes
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Contact lens wetting solution
Opti-Free Puremoist by Alcon Laboratories, Inc. — Class II — MDR, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Contact lens wetting solution.
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- BLINK-N-CLEAN — WOONSOCKET PRESCRIPTION CENTER, INCORPORATED · Class II
- BLINK CONTACTS — Johnson & Johnson Surgical Vision, Inc. · Class II
- Bausch + Lomb — Bausch & Lomb Incorporated · Class II
- Biotrue® Hydration Boost Contact Lens Rehydrating Drops — Bausch & Lomb Incorporated · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDR
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDR | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
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Manufacturer
- Manufacturer
- Alcon Laboratories, Inc.
Sources (2)
- FDA UDI c25066b9-6b50-4d1f-8ba1-3a75cb12985b 34 fields · synced Aug 1, 2026
- EUDAMED cccacd1a-5649-43f6-8a01-9ee29b0f3c0b 61 fields · synced Aug 1, 2026