Spectralis, HEP
Catalogue number Image Capture Module SW V1.2.4, listed by Heidelberg Engineering Gmbh, Germany, under Perimeter, Ac-Powered. 1 manufacturer in China is registered for this product code.
1manufacturer
1catalogue number
Who Else Makes It
Registered in Jiangsu.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Link Instruments Co., Ltd. | Changzhou | Jiangsu | Manufacturer | 21 |
Record
| Listed by | Heidelberg Engineering Gmbh, Germany |
|---|---|
| FDA product code | HOO |
| Device type | Perimeter, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 886.1605 |
| Establishment | Manufacturer |
| Record published | 2018-07-11 |
| Record revised | 2026-04-13 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Image Capture Module SW V1.2.4 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Humphrey Matrix | Carl Zeiss Meditec Inc | 1 |
| Takagi | Takagi Seiko Co., Ltd. | 1 |
| Easyfield C | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 1 |
| HEP | Heidelberg Engineering Gmbh | 1 |
| Humphrey FDT | Carl Zeiss Meditec Inc | 1 |
| Easyfield S | Oculus Optikgeräte Gesellschaft mit beschränkter Haftung | 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.