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Sign in to claim this brandHeidelberg Engineering
US
Last updated May 23, 2026
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Catalogue (60)
Page 1 of 2| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Spectralis | Software with HEYEX 2 V7.0-US | FDA UDI | Class II | Active |
| Spectralis | S3610 [SN>20000] | FDA UDI | Class II | Active |
| Spectralis | Software with HEYEX 2 V6.14_US | FDA UDI | Class II | Active |
| Spectralis | SP-PWS-2001A [>20000] | FDA UDI | Class II | Active |
| Spectralis | Image Capture Module SW V1.2 | FDA UDI | Class II | Active |
| Spectralis | SPEC-CAM-S1610 | FDA UDI | Class II | Active |
| Spectralis | Software V.7.2-US | FDA UDI | Class II | Active |
| Hep | HEP with HEYEX 2 SW V3.2c | FDA UDI | Class I | Unknown |
| Hrt3 | HRT3 RCM | FDA UDI | Class II | Unknown |
| Tomocap | N/A | FDA UDI | Class II | Active |
| Spectralis | SP-PWS-1000A | FDA UDI | Class II | Active |
| Spectralis | S1002 | FDA UDI | Class II | Active |
| Anterion | Software with HEYEX 2 V1.2.3 | FDA UDI | Class II | Active |
| Spectralis | Software V7.0-US | FDA UDI | Class II | Active |
| Spectralis | Product Family SW V6.8a-US | FDA UDI | Class II | Active |
| Spectralis | Product Family SW V6.9.1-US | FDA UDI | Class II | Active |
| Anterion | Software V.1.2.4 US | FDA UDI | Class II | Active |
| Spectralis | Software V6.10-US | FDA UDI | Class II | Active |
| Spectralis | SPEC-CAM-S3610 | FDA UDI | Class II | Active |
| Spectralis | HMO | FDA UDI | Class II | Active |
| Spectralis | SPEC-TSP | FDA UDI | Class II | Active |
| Spectralis | SP-PWS-1001A | FDA UDI | Class II | Active |
| Spectralis | Product Family SW V6.8-US | FDA UDI | Class II | Unknown |
| Spectralis | Software 6.13_US | FDA UDI | Class II | Active |
| Spectralis | Software V.7.2-US with Heidelberg Eye Explorer | FDA UDI | Class II | Active |
| Spectralis | Software 6.12_US | FDA UDI | Class II | Active |
| Anterion | Software V.1.5 US | FDA UDI | Class II | Active |
| Spectralis | SPEC-CAM-S2600 | FDA UDI | Class II | Active |
| Spectralis | S2002 | FDA UDI | Class II | Active |
| Spectralis | SPEC-CAM-S2000 | FDA UDI | Class II | Active |
| Spectralis | S2610 [SN>20000] | FDA UDI | Class II | Active |
| Anterion | 88036 | FDA UDI | Class II | Active |
| Spectralis | SPEC-CAM-S2610 | FDA UDI | Class II | Active |
| Spectralis, Hep | Image Capture Module SW V1.2.4 | FDA UDI | Class I | Active |
| Spectralis | VAO | FDA UDI | Class II | Active |
| Spectralis | 86549 | FDA UDI | Class II | Active |
| Spectralis | SP-PWS-2000A | FDA UDI | Class II | Active |
| Spectralis | SPEC-CAM-S1600 | FDA UDI | Class II | Active |
| Hrt3 | HRT3 RCM | FDA UDI | Class II | Active |
| Spectralis | SP-PWS-2001A | FDA UDI | Class II | Active |
| Spectralis | Software with HEYEX 2 V6.10-US | FDA UDI | Class II | Active |
| Spectralis | Product Family SW V6.6 | FDA UDI | Class II | Active |
| Hrt3 | Rostock Cornea Module SW V1.5a | FDA UDI | Class II | Active |
| Spectralis | UWF1 | FDA UDI | Class II | Active |
| Spectralis | SPEC-CAM-S3600 | FDA UDI | Class II | Active |
| Spectralis | Software with HEYEX 2 V6.12_US | FDA UDI | Class II | Active |
| Anterion | 88036 | FDA UDI | Class II | Active |
| Spectralis | Product Famliy with HEYEX 2 SW V6.9b-US | FDA UDI | Class II | Active |
| Spectralis | WFO2 | FDA UDI | Class II | Active |
| Hrt3 | Rostock Cornea Module SW V1.5 | FDA UDI | Class II | Active |
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