Bioseal Inc.
Danz Corneal Shield Medium
384manufacturers in China registered for this device type
16catalogue numbers in this listing
Who Else Makes It
Concentrated in Zhejiang (157), Guangdong (78), Jiangsu (42). 39 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Shanghai Joy Crown Industry Co., Ltd. | Pu Dong New Area | Shanghai | Contract manufacturer | 64 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
| Zhejiang Gongdong Medical Technology Co., Ltd. | Taizhou | Zhejiang | Contract manufacturer | 40 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Zhongshan Chukuang Textile Co., Ltd. | Zhongshan | Guangdong | Contract manufacturer | 26 |
| Nanchang White Technology Co., Ltd. | Nanchang | Jiangxi | Contract manufacturer | 21 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Global Fabtech Wheel Chair (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 15 |
| Jiangxi Dentalbright Technology Co., Ltd. | Jiujiang | Jiangxi | Contract manufacturer | 12 |
| Shenzhen Yicai Health Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 10 |
Showing 12 of 384. All 384 manufacturers in China registered for Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
Record
| Listed by | Bioseal, United States |
|---|---|
| FDA product code | HOY |
| Device type | Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4750 |
| Establishment | Contract manufacturer, Contract steriliser, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-01-29 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
| Packaging | Case of 20, case of 12, case of 24, case of 25 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 551S/20 | In distribution | |
| 539A/20 | In distribution | |
| 551L/20 | In distribution | |
| 18345/24 | In distribution | |
| 551RS/20 | In distribution | |
| 551M/20 | In distribution | |
| 540SO/12 | In distribution | |
| 540MG/12 | In distribution | |
| 537C/20 | In distribution | |
| 18341/24 | In distribution | |
| 550CS/25 | In distribution | |
| 551R/20 | In distribution | |
| 537-A/20 | In distribution | |
| 551RL/20 | In distribution | |
| 54001/12 | In distribution | |
| 540LC/12 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| MSI Precision Specialty Instruments | MED Saver, Inc. | 58 |
| maxill Frames Eyewear Adult | Maxill, Inc. | 30 |
| Hayden Medical | Hayden Medical Inc | 28 |
| Plasdent | Plasdent Corp. | 26 |
| Clear Choice | Southmedic, Inc. | 22 |
| Surgical Eye Shield | Jardon EYE Prosthetics, Inc. | 20 |
| Hyper Tough | EYE OJO Corp. | 18 |
| Marina Medical | Marina Medical Instruments, Inc. | 17 |
| Snow Goggle | Hunan Yofe Technical Optics Co., Ltd. | 16 |
| Ease-In-Shields | Ultradent Products Inc. | 16 |
| Ozark Trail | EYE OJO Corp. | 10 |
| Eye Shield | Katena Products, Inc. | 10 |
Showing 12 of 222. All products under Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
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.