Qualis
HDK Daily Contact Lens_30pk
4manufacturers in China registered for this device type
117catalogue numbers in this listing
Who Else Makes It
Concentrated in Hong Kong (2), Hunan (1), Guangdong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Objectt Optik Company Limited | Hong Kong | Hong Kong | Contract manufacturer | 8 |
| Bloom MAX Limited | Central | Hong Kong | Manufacturer | 3 |
| Hunan Haipuming Technology Co., Ltd. | Shaoyang | Hunan | Manufacturer | 2 |
| Shenzhen Dashicheng Optical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 2 |
Record
| Listed by | Unicon Optical Co., Ltd., Taiwan |
|---|---|
| FDA product code | MVN |
| Device type | Lens, Contact, (Disposable) |
| Device class | Class 2 |
| Regulation | 21 CFR 886.5925 |
| Establishment | Contract manufacturer, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-07-01 |
| Record revised | 2023-05-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Latex | Contains natural rubber latex |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| +5.00 | In distribution | |
| -2.75 | In distribution | |
| +1.75 | In distribution | |
| -2.25 | In distribution | |
| -2.25 | In distribution | |
| -2.50 | In distribution | |
| +1.75 | In distribution | |
| -1.00 | In distribution | |
| -0.75 | In distribution | |
| +3.25 | In distribution | |
| -6.00 | In distribution | |
| -6.50 | In distribution | |
| +3.75 | In distribution | |
| -4.00 | In distribution | |
| -4.75 | In distribution | |
| -7.00 | In distribution | |
| -1.25 | In distribution | |
| +4.75 | In distribution | |
| -10.00 | In distribution | |
| -3.50 | In distribution | |
| -5.75 | In distribution | |
| -1.75 | In distribution | |
| -4.25 | In distribution | |
| -10.50 | In distribution | |
| -10.00 | In distribution | |
| -4.25 | In distribution | |
| -5.00 | In distribution | |
| +1.00 | In distribution | |
| -4.50 | In distribution | |
| +4.25 | In distribution | |
| -0.50 | In distribution | |
| -3.00 | In distribution | |
| -11.50 | In distribution | |
| +2.50 | In distribution | |
| -9.00 | In distribution | |
| +5.75 | In distribution | |
| -1.50 | In distribution | |
| -5.25 | In distribution | |
| -3.25 | In distribution | |
| +4.00 | In distribution | |
| +6.00 | In distribution | |
| +5.00 | In distribution | |
| +2.75 | In distribution | |
| -12.00 | In distribution | |
| +3.50 | In distribution | |
| -8.00 | In distribution | |
| -9.50 | In distribution | |
| -3.25 | In distribution | |
| +1.25 | In distribution | |
| -2.75 | In distribution | |
| -0.50 | In distribution | |
| -5.00 | In distribution | |
| -1.50 | In distribution | |
| +4.75 | In distribution | |
| -3.00 | In distribution | |
| +2.00 | In distribution | |
| +3.75 | In distribution | |
| -5.25 | In distribution | |
| -8.00 | In distribution | |
| -8.50 | In distribution | |
| +3.00 | In distribution | |
| +2.25 | In distribution | |
| -4.00 | In distribution | |
| +0.75 | In distribution | |
| +2.75 | In distribution | |
| +0.75 | In distribution | |
| -6.50 | In distribution | |
| -7.00 | In distribution | |
| -7.50 | In distribution | |
| -11.00 | In distribution | |
| -9.00 | In distribution | |
| +5.25 | In distribution | |
| -3.75 | In distribution | |
| +0.25 | In distribution | |
| +5.25 | In distribution | |
| -5.50 | In distribution | |
| +5.75 | In distribution | |
| -8.50 | In distribution | |
| -12.00 | In distribution | |
| +1.50 | In distribution | |
| -2.00 | In distribution | |
| -11.00 | In distribution | |
| +4.25 | In distribution | |
| +3.50 | In distribution | |
| -10.50 | In distribution | |
| -1.00 | In distribution | |
| -11.50 | In distribution | |
| -6.00 | In distribution | |
| -2.50 | In distribution | |
| -5.50 | In distribution | |
| -2.00 | In distribution | |
| -4.75 | In distribution | |
| +4.00 | In distribution | |
| +0.50 | In distribution | |
| +1.00 | In distribution | |
| +5.50 | In distribution | |
| +6.00 | In distribution | |
| +3.25 | In distribution | |
| -5.75 | In distribution | |
| +3.00 | In distribution | |
| +4.50 | In distribution | |
| -1.75 | In distribution | |
| -4.50 | In distribution | |
| +5.50 | In distribution | |
| +0.50 | In distribution | |
| -3.50 | In distribution | |
| +1.25 | In distribution | |
| +2.00 | In distribution | |
| +1.50 | In distribution | |
| +4.50 | In distribution | |
| +2.50 | In distribution | |
| +2.25 | In distribution | |
| -3.75 | In distribution | |
| -0.75 | In distribution | |
| -9.50 | In distribution | |
| -1.25 | In distribution | |
| +0.25 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| ZonedIn Contact Lenses | Zonedin Vision LLC | 215 |
| ZonedIn Vision Contact Lenses | Zonedin Vision LLC | 66 |
| Ideal SiHy/1Day/30PK | Vizionfocus Inc. | 55 |
| Aveo Hello | Supervision Optimax SDN BHD | 53 |
| ProOcular Daily Disposable Contact Lens | Carlsbad Technology Inc. | 29 |
| PolyVue HD Dailies | Interojo Inc. | 4 |
| FreshKon® 1-Day (Etafilcon A) | Oculus, Inc. | 1 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.