Bausch + Lomb
Whitman DBL Ended LRI Marker
2manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Beijing (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Beijing Hongdee Corporation | Beijing | Beijing | Private-label distributor | 43 |
| Huaian Frimen Co., Ltd. | Huaian | Jiangsu | Manufacturer | 16 |
Record
| Listed by | Bausch & Lomb Incorporated, United States |
|---|---|
| FDA product code | HJB |
| Device type | Instrument, Measuring, Corneal Radius |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1450 |
| Establishment | Remanufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2025-08-04 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| E2427 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Walcott Rx Products | Walcott Rx Product Inc | 60 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 25 |
| Atlas Corneal Topography System | Carl Zeiss Meditec 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.