Identity
- Trade Name
- Qualis FDA UDI
- Generic Name
- Soft corrective contact lens, daily-wear FDA UDI
- Device Name
- HDK Daily Contact Lens_5pk FDA UDI
- Model / Reference
- +3.50 FDA UDI
- Description
- HDK Daily Contact Lens_5pk FDA UDI
Identifiers
- Primary DI / UDI-DI
- 04719881883669 FDA UDI
- FDA Product Code
- MVN FDA UDILPL FDA UDI
- GMDN Term
- Soft corrective contact lens, daily-wear FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 886.5925 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
Yes
FDA UDI
Single Use
Yes
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
No
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
Yes
FDA UDI
Lot / Batch Number
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
Yes
FDA UDI
Manufacturing Date
No
FDA UDI
Category: Soft corrective contact lens, daily-wear
Qualis by Unicon Optical Co., Ltd. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
Similar devices
Also classified as Soft corrective contact lens, daily-wear.
- HAPA KRISTIN — INTEROJO INC. · Class II
- clear55A — CLEARLAB SG PTE. LTD. · Class II
- Loox — Camden Passage Inc · Class II
- PolyVue — INTEROJO INC. · Class II
- HAPA KRISTIN — INTEROJO INC. · Class II
- Loox — Camden Passage Inc · Class II
- ArtMost SoftOK Daily Wear Soft Contact Lens — SEINOH OPTICAL CO., LTD. · Class II
- ArtMost SoftOK Daily Wear Soft Contact Lens — SEINOH OPTICAL CO., LTD. · Class II
Authorization Coverage (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Unicon Optical Co., Ltd.
Sources (1)
- FDA UDI d04c55db-4fd7-4f53-ba4d-4b4469d650c3 33 fields · synced Jun 8, 2026