Bilband
Biliband Premature 24-33 cm
6manufacturers in China registered for this device type
1catalogue number
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 | Natus Medical Denmark ApS, Denmark |
|---|---|
| FDA product code | FOK |
| Device type | Pad, Neonatal Eye |
| Device class | Class 1 |
| Regulation | 21 CFR 880.5270 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-10-14 |
| Record revised | 2025-10-30 (version 2) |
Specifications
| MRI safety | MR Unsafe |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, expiry date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 900643 | 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 |
| DeRoyal | Deroyal Industries, Inc. | 8 |
| 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 |
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.