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Qualis

FDA UDI

Class II (US FDA UDI)

by Unicon Optical Co., Ltd.

Identity

Trade Name
Qualis FDA UDI
Generic Name
Soft corrective contact lens, daily-wear FDA UDI
Device Name
HDK Daily Contact Lens_30pk FDA UDI
Model / Reference
+1.50 FDA UDI
Description
HDK Daily Contact Lens_30pk FDA UDI

Identifiers

Primary DI / UDI-DI
04719880078875 FDA UDI
FDA Product Code
MVN FDA UDI
LPL 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.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

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Manufacturer

Manufacturer
Unicon Optical Co., Ltd.

Sources (1)

  • FDA UDI 3c71f4a6-4e89-4bc0-b7fe-1ce4a3794d8d 33 fields · synced May 30, 2026