DeRoyal
Neonatal Eye Cover
6manufacturers in China registered for this device type
8catalogue numbers in this listing
Who Else Makes It
Concentrated in Jiangsu (3), Guangdong (2), Sichuan (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Farstar (Wuxi) Medical Equipment Co., Ltd. | Wuxi | Jiangsu | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Jiangsu Hongsheng Bioengineering Co., Ltd. | Nantong | Jiangsu | Manufacturer | 28 |
| Unimed Medical Supplies Inc | Shenzhen | Guangdong | Contract manufacturer | 15 |
| Guangdong Tidakang Medical Technology Co., Ltd. | Zhongshan | Guangdong | Manufacturer | 12 |
| Auckland Medical Technology (Sichuan) Co., Ltd. | Luzhou | Sichuan | Manufacturer | 3 |
Record
| Listed by | Deroyal Industries, Inc., United States |
|---|---|
| FDA product code | FOK |
| Device type | Pad, Neonatal Eye |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5270 |
| Establishment | Contract manufacturer, Contract steriliser, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2021-07-12 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Case of 12, box of 12 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 72-4201 | In distribution | |
| 72-4202 | In distribution | |
| 72-4100 | In distribution | |
| 72-4102 | In distribution | |
| 72-4302 | In distribution | |
| 72-4301 | In distribution | |
| 72-4101 | In distribution | |
| 72-4200 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| EyeMax2 | Maxtec, LLC | 23 |
| NeoShades® with Tabs | Neotech Products, LLC | 12 |
| NeoShades® with Headstrap | Neotech Products, LLC | 9 |
| Bili-Bonnet | Small Beginnings Inc. | 3 |
| Posey Eye Protection | Neolight, LLC | 3 |
| Biliband | Natus Medical Denmark ApS | 2 |
| Posey | Posey Products, LLC | 2 |
| Argyle | Cardinal Health | 2 |
| WeeSpecs Infant Eye Protection | International Biomedical, Ltd. | 1 |
| Posey EYE Protectors | Posey Products, LLC | 1 |
| Bilband | Natus Medical Denmark ApS | 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.