Leica HD C100
Leica HD C100 for all microscopes except OHs - Accessory for Leica surgical operating microscope systems
1manufacturer
3catalogue numbers in this listing
Who Else Makes It
Registered in Jiangsu. One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Altek Medical (kunshan) limited | Kunshan Free Trade Zone | Jiangsu | Contract manufacturer | 2 |
Record
| Listed by | Leica Microsystems (Schweiz) AG, Switzerland |
|---|---|
| FDA product code | FTT |
| Device type | Camera, Still, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 878.4160 |
| Establishment | Specification developer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-09-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 000000000010449018 | In distribution | |
| 000000000010449016 | In distribution | |
| 000000000010449017 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Digital Medical Scope | Nidek Incorporated | 2 |
| RCS 100 Camera with dermatoscope, otoscope and | Rudolf Riester Gmbh | 1 |
| RCS-100 camera | Rudolf Riester Gmbh | 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.